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http://finance.yahoo.com/news/teva-announces-favorable-european-patent-185000594.html
TEVA copaxone patent 2025 in EU
Any thoughts why 20% short interest? Big funds buying, PPS went way up, court verdict can't be much worse, former pfe CEO on board...
Even if case goes pip's way again damages could be greatly reduced. And stock is still cheap. Any serious thoughts appreciated.
I am long >4,000 shares but just trying to see the other side. And a simple "pip will win" answer will not do. Tia.
PPS has been cut in half in less than two months. I hope they say something positive at the meeting this Monday in Montreal to stop the bleeding.
Most people here are probably holding anyway. What's the difference if you have a 50% loss versus a 75% loss?
The real question is will 2013 be the year this company truly moves forward and will they have the backing to do it? Stay tuned.....
YHOO MB is a complete joke. Absolutely horrible format.
I can barely even stand to read it. Finding the last post is harder than reading a 10Q.
Jumping through messages just as miserable. And paid bashers (and pumpers) galore.
Well......I hope October is the month we finally get some good news. My account is down 7% today. But it could always be worse.
Look at the poor folks who held QCOR through yesterday's debacle.
Anyway.....GLTY and anyone else on this board. It certainly is quiet here sometimes......
Today is a beating. This isn't on light volume. It's on 4x normal volume. So perhaps someone is thinking:
1. delisting is likely even if it won't occur until 2013
2. management may not be able to commercially produce wire
3. machines will be further delayed
4. or no partnership
I don't think this is just shorty. But then again, who ever knows?
BTW I bought 5000 shares today at 50. Even that is now 10% down.
As we get closer to machines being implemented and wires being produced, why has share price eroded so much? You would think we would of seen some stabilization the further out we go?
Stock was stuck in the 60's for some time. Now condemned to the 50's. I can only think people are nervous about delisting or shorts are playing games. What other possibilities exist?
Where do you see PPS by EOY?
NAVB......reminding me what is often inevitable when too many shorts are on the wrong side of the fence.
Rule #1 of biotech investing: nothing is a lock pick.
Rule #2: have dry powder ready, just in case.
Rule #3: have strong knees and stronger stomach.
Let's see where this closes today?
Wasn't that an issue with avnr's drug? But FDA approved it after just lowering the dose.
If your point is that this isn't apples to apples, then I agree.
No matter what case we look at, pancreatic enzymes, heparin, it's not apples to apples.
But I think having read about those both, I can understand where AMRN is going with this and why they fought to have NCE approval.
IRISH company or not, FDA would not tell them if nce was approved or not. That ain't how it works.
At this point, it hardly matters. PPS is so depressed no nce would be a non-event.
But I still believe that EPA can be treated separately--only 3 weeks left to find out. I don't think AMRN would have spent the time to promote this and run an outcome study if they did not feel that the odds were favorable to them? Is that also wrong to assume?
Any drug has an effect.
But the mechanism for Lovaza is UNKNOWN.
DHA reduces TG's better than EPA.
FDA will view this like they did with heparin. Both drugs have EPA, but b/c amrn purified it, they can grant it nce status as well.
The heparin example with lovenox seems to be quite similar to this situation in my eyes, and I believe that is why the fDA asked them to perform reduce-it.
I may be in the minority here, but I feel this will be the exception to the rule.
"New chemical entity means a drug that contains no active moiety that has been approved** by FDA in any other application submitted under section 505(b) of the act."
Negative for AMRN: Approved refers to the active ingredient alone or in combination (i.e. Lovaza)
Positive for AMRN: Active moiety is "the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance."
So what is responsible for the physiological or pharmacological action of Lovaza? Is it it EPA. No. B/c EPA at a high dose has shown to lower LDL's, something Lovaza doesn't do. DHA lowers trigs, and even FDA doesn't list the actual mechanism for Lovaza.
Their active ingredients are also listed differently.
I think AMRN will say that mixture is one thing. There's is separate and produced an unexpected result, lowering LDL's only attributed to highly purified EPA.
Look at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/02/dc-district-court-grants-fda-summary-judgment-in-generic-lovenox-dispute.html
How is it that there are tens of heparin products but lovenox got nce?
Because additional scientific study and purification processes helped generate new, not yet approved, active moieties, in the FDA's view. Otherwise, isn't LMW heparin the same as lovenox?
Why would fda make amrn do a true outcome study? Omthera didn't have one. Why was Kurst who writes the FDA blog for years in the room with FDA and other AMRN attorneys?
Because they likely went over which patents would be included in orange book IF nce were approved. By the way, orange book for July came out on thursday, so I think August 16th is likely when we will know with official print the next day.
For now, the stock bleeds............
Many people enjoy trading biotechs, because they move so violently allowing for quick gains up or down. But one has to be careful, because sometimes you can miss a BIG move by doing so. I bought ECYT around $3. When it hit $3.83, my 10,000 shares looked to have been a great investment. So I sold. Next day, the stock broke through $6. Hope I made my point. (Similarly, I wanted to buy KERX puts for 55 cents rather than 60. I week later, after CRL, they were $2.55. Moral: Stick with your guns. If your research is good, you will LIKELY be vindicated, and a few cents here or there can mean missing big dollars elsewhere.)
AMRN has two SPA agreements with the FDA. And while having an SPA is no guarantee for approval, in this case it ALMOST is.
http://seekingalpha.com/article/235470-3-upcoming-fda-decisions-to-watch-closely
AMRN has TWO phase III studies that both showed safety and efficacy. The only way they get rejected is either manufacturing or something of the like. So there can still be a delay and there can still be a CRL, but it would only kill options players, as the drug would still be ultimately approved. (And based on what the CEO said yesterday, manufacturing may be a GO.)
Remember, MARINE is one thing, ANCHOR another. When this PDUFA is over with, AMRN will file another NDA for ANCHOR. This too will be a big deal. People think filing an NDA is like doing a book report. The document literally has thousands of pages. It takes a lot of time to insure all the t's and i's are in order.
But Lovaza helped Reliant sell for over $1.6 Billion which in today's market is almost $2 billion adjusted for inflation. And that's like saying AMRN would be worth $2B for Marine only. With ANCHOR, the numbers start to move more exponentially.
This is from June 2011.
http://www.gekkowire.com/?p=6477
His estimates are more conservative, but I think they are fair. Remember, that's not including ANCHOR.
If you think that we will see $20 this year, wait another year, when buyout or partnership or ANCHOR NDA is accepted. You ain't seen nothing yet.
I think they will get bought out, if BP is willing to pay the price. But I can't realistically phathom a price below $30. Because with the value of anchor, this stock could be $50 in 2-3 years without a buyout.
We shall see..........
I think a lot of people think this is just AMRN rising because on of its competitors demonstrated weak results. But it's really more than that.
http://www.theflyonthewall.com/permalinks/entry.php/AMRNid1618156/AMRN-Amarin-management-to-meet-with-Lazard-Capital
If you are big pharma, normally you wait for approval to buy a company. (A bird in the hand is worth two in the bush.) Most would rather pay up for something that's a done deal than take a big risk. Well, in this case, you have two successful Phase III studies. You have a drug that is now obviously "best in breed." And you have a company with great financials.
Companies don't have to "worry" as much about the competition, because it's obvious that if they market this correctly, it can wipe out most of the competition. This is good news for AMRN because a competitor came out with lackluster results--perhaps worse than Lovaza. But it's bigger, because it means now big pharma can truly look to acquire this company, if they allow it.
Also, with more favorable patent rulings ahead, more PPS appreciation is likely. People think tomorrow will be a down day. Not so sure. Upgrades may continue to ring in. And either way, it is obvious that after today, the rules have certainly changed. There has to be doubt, or we would be at $20 already.
Many worried that when VVUS and NAVB got notices of 3 month delays by FDA that AMRN would follow. Same people who refuse to see how this drug is SUBSTANTIALLY better than anything else available. FDA may be swamped, but I still believe we get our answer before July.
Tomorrow may be an up day or down day for AMRN. But the ceo's phone sure as hell will be ringing. Don't bet on a buyout. But even without, the potential here has finally started to come to fruition. Patent news and approval are only 1 day closer than yesterday. But the possibility that big pharma starts knocking at the door just improved exponentially.
The link worked for me. Here it is again:
See more news releases in: Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, Clinical Trials & Medical Discoveries
Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
0 0 0
Epanova™ Achieved Primary Endpoint for Triglyceride Lowering At All Three Doses (2, 3, 4 grams)
PRINCETON, N.J., April 26, 2012 /PRNewswire/ -- Omthera Pharmaceuticals, Inc., a privately held specialty pharmaceuticals company, today announced positive top-line data from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) clinical study for Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. The Phase 3 clinical trial randomized 399 subjects with triglyceride levels of 500-2000 mg/dl to 2, 3, or 4 grams of Epanova, or 4 grams of olive oil for a total of 12 weeks of treatment. The primary endpoint of the trial was the percentage change in triglyceride level from baseline to week 12, and the secondary endpoint was the reduction in non-HDL-cholesterol. The top-line results demonstrated highly statistically significant reduction of triglycerides in all dose groups, with median decreases in triglycerides from baseline to end of treatment of approximately 26% in the 2 gram cohort and 31% for those subjects on the 4 gram dose. Furthermore, Epanova appeared safe and well tolerated, with discontinuation rates due to adverse events, primarily gastrointestinal, ranging from 5% to 7% across all dosing groups.
Commenting on the results, Jerry Wisler, Chief Executive Officer and Co-Founder of Omthera, stated, "We are pleased by the comprehensive lipid benefits shown by Epanova in the EVOLVE study - especially at the 2 gram dose, which demonstrated triglyceride lowering comparable to that of 4 gram doses of other prescription omega-3 products. This comparable efficacy of Epanova at a significantly lower dose supports the prior demonstration of improved bioavailability of this free fatty acid formulation versus the ethyl ester form found in other prescription Omega 3 products. The preliminary data also showed dose-dependent increases in plasma EPA and DHA levels with Epanova. We look forward to completing a comprehensive analysis of the study and aim to present the complete data set at an upcoming scientific meeting."
Dr. Michael Davidson, Co-Founder and Chief Medical Officer of Omthera, stated, "In addition to the triglyceride lowering benefit, we were pleased to observe from these top-line results a meaningful decrease of 8% in non-HDL-cholesterol in both the 2 and 4 gram dose groups. We believe these data will be important for Epanova in light of the growing reliance of the medical community (Journal of the American Medical Association, March 28, 2012 – Vol 307, No 12) on non-HDL-cholesterol as the more accurate arbiter of the risk for cardiovascular disease, especially in patients with hypertriglyceridemia. We have recently completed enrollment and randomization in ESPRIT, our 647 patient statin combination study. The primary objective of ESPRIT is to evaluate the efficacy of adding Epanova (2 gram or 4 gram daily) to statin monotherapy for lowering non-HDL-cholesterol. We look forward to the results from this study, expected in July 2012, to further validate the progression of Epanova as a best-in-class therapy for the treatment of patients with mixed dyslipidemia."
About Epanova™
Epanova is a patent protected, novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Omthera has developed a substantial body of data on Epanova, which points to an improved and more predictable bioavailability as compared to the ethyl ester form found in prescription Omega-3 products currently available. Triglyceride lowering with Epanova was previously observed in two large, placebo-controlled, randomized, double-blind, Phase III studies involving 748 Crohn's disease patients with normal triglyceride levels for =52 weeks, approximately 400 of which were treated with Epanova for remission of disease. In all studies performed to date, Epanova has demonstrated a very good safety and tolerability profile.
About Hypertriglyceridemia
Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased risk of heart disease. It is one component of a range of lipid disorders collectively referred to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed to be in excess of 100 million, with approximately 35 million of those diagnosed with hypertriglyceridemia (triglycerides greater than 200mg/dL) and an estimated 5 million with very high triglyceride levels (triglycerides greater than 500mg/dL). Very high triglycerides are associated with an increased risk of pancreatitis. Regulatory approval for the treatment of very high triglycerides is based on a significant reduction in the serum triglyceride levels.
About Omthera Pharmaceuticals, Inc.
Founded in 2008, Omthera Pharmaceuticals, Inc. is a privately held, specialty pharmaceutical company focusing its efforts on the clinical development of new therapies for dyslipidemia. Led by a team of experts with exceptional experience in developing new therapies for lipid disorders, Omthera is dedicated to developing innovative therapies for the millions of patients who have elevated triglyceride levels and increased risk of cardiovascular disease. Omthera holds worldwide rights to Epanova under a license from Chrysalis Pharma AG, a privately held Swiss company that is the owner of the product. For more information, please visit www.omthera.com
Astra Ceo stepping down and Omthera results out:
http://online.wsj.com/article/SB10001424052702304811304577367150881712224.html
http://www.prnewswire.com/news-releases/omthera-pharmaceuticals-announces-positive-top-line-results-from-phase-3-evolve-study-149040575.html
P.S. at 10.50 premarket. My take is results are good but not stellar. Trigs did not go down 60% as previously hoped for. And I can't see what LDL's did? Probably see a pop initially. This was hanging over many investor's heads. Let's see what today will bring?
Bottom line: this may be good news for AMRN
Over $8 and rising...
Last two conferences were loaded with info. Yesterday was very good but I was disappointed that there was no Q & A. Well disappointed no further. Today's was all Q&A.
Bottom line: March will be critical. FDA will meet with ECYT in 2nd week to answer all questions. For instance, will trial be only 200 patients or 600. The less people the cheaper and lower cash burn.
Will it include + only or ++ patients?
Can they use doxil or new med from india?
For those with real interest, I suggest you listen to the last two days worth of information. By March we could know a lot of things that are currently weighing on the stock.
Let's see............................
Thanks for the post. Couple of things I just wanted to add. All minor points, perhaps:
ECYT was told in August that their drug would be under review for about 57 days to achieve this status (along with drugs from other companies.) It took 6 months, wow.
http://www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_report/2011/10/WC500116272.pdf
If they do get approved in EU, orphan drug status usually allows for 10 years of marketing exclusivity.
http://en.wikipedia.org/wiki/Orphan_drug_status
And finally, the feb 9th news didn't seem to impact the stock. It closed up 2 cents. The 14th and 15th of Feb is when we finally saw saw real buying on heavy volume. Not sure if it was a delayed response, value investors, or what?
Let's see what next two days tell us. March will be important. We have earnings and possible news end of month. But first........to tomorrow............
http://investor.endocyte.com/events.cfm
Let's just move on......shall we?
Tonoos posted this:
http://www.investorvillage.com/groups.asp?mb=16085&mn=7834&pt=msg&mid=11063613
I don't agree. I stick with my previous analysis. (Not that anyone can be certain, of course.)
If NDA were to be rejected, I think $2.21 would look like a pretty high price. We did just hit $1.62 about a month ago, remember?
I think this was a short covering some of his position. Or this was an attempt to see if they can do this again and REALLY knock out more retail stops next time. The more battle tested we are, though, the less weaker hands remain. And the worse prognosis for shorts, if NEOP is vindicated.
Less than 1 week to go.......
P.S. Is anyone considering a straddle to try to make some short gains on serious price movement? I'm not sure if it can be done with how low the price is, to be meaningful. Just a thought for the more saavy traders........I don't include myself in that category BTW.
While what we say today was not a true bear raid by definition, for all practical purposes that is what occurred. (Figures I'm away from the computer all day. Maybe that's better.........)
If you're a short and are worried that volume is anemic and you can't cover without losing big what would you do? You put up some big blocks to cause the stock to drop and knock out the retail stops. It's a proven protocol for small biotech stocks. And around binary events, it's more effective. More people are concerned they'll lose their skin so they place stops. These stops get wiped out and now shorty can buy back in at a lower price. He can effectively cover his short and make $$$ or buy the stock on the cheap and go long to negate some of his short position. A double win.
Here's a post on yahoo from someone I respect that may elaborate better:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_N/threadview?m=tm&bn=123114&tid=31920&mid=31947&tof=15&rt=2&frt=1&off=1
Now....if nothing has changed, meaning no news is out, and the stock recovers, what does that mean?
It's a bullish sign. Likely, shorty is either concerned he's on the wrong side of the trade, or something illegal (insider trading) has leaked. If it's the latter, we can be certain the stock will go up. If it's the former, we cannot be; but it still bodes well for longs. Because it means shorts are covering.
I described a situation last week where this exact thing occurred:
http://ragingbull.quote.com/mboard/boards.cgi?board=NEOP&read=21677
Anyway...if PPS rebounds--and I think it will tomorrow---I would expect NDA acceptance news THIS WEEK. I know this is my speculation. But I'm going by past experiences. While each stock and event is different, I believe certain patterns are traceable and reproducable. We shall see.
This is my take on what occurred. Feel free to agree or disagree. But always keep some powder around for the next suspect move to occur. So that you can profit from it.....if you're by a computer, of course.
No worries. The next two weeks should quiet things down. Either the shorts win and this thing goes down. Or management gets another feather in their hat.
Volume has been anemic. Everyone is waiting, one way or another.
And so we wait.......
My last post was removed due to one foul word. The remaining 15 minutes of what I wrote went down the tubes because of it. I would appreciate it, if they would not be so callous. Otherwise, why post here? Arguing is fine. Name calling and vile language is another.
What happened to make you so jaded Invest2win? I remember the days when you were a perennial NEOP long? Perhaps you still are? Who knows?
I'll make the points that I tried to previously convey, but with less synopsis. I'm tired of writing things twice.
1. Management has done everything it can to start achieving milestone after milestone. While Bupp deserves some credit for not allowing this company to go the way of the dinosaur, he also made plenty of mistakes that cost us (NEOP longs) time and $$$. Since the start of the year, we joined AMEX, completed Phase III, and filed NDA.
Unlike most companies, NEOP always responded immediately to any threats, i.e. Shrkeli's article/petition and SC's approval. How many companies do that? Very few. But to a small biotech, it's crucial. Shorts and misinformation has been known to kill and slow many a good company. I don't feel like going into this, but this is not my opinion. Plenty of examples exist as proof.
So I feel we should give THIS new management team the benefit of the doubt. We shall see in a week or so.....
2. Shrkeli is suspect. But that doesn't make him a crook, crazy, or b.s. artist. He manipulated things to achieve what he wanted. But if what he said was completely false, no pps depreciation would have occurred. The reason it did was b/c:
a: there is some truth to what he says. by that, I mean nothing is guaranteed. FDA could decide the glass is half empty, and they chose wrong comparison. (I am long over 15000 shares so you know that's not what I believe. Had to put that in before people start screaming basher over here.)
b: BUPP sold many shares at that exact time. In his fairness, he tabled the rest when he saw how much carnage was taking place.
c: many people bought on margin, due to momentum and faced margin calls
d: many weak retail longs bailed when the sky appeared to be falling. IF EVERYONE KNEW WHAT THIS COMPANY WAS REALLY ABOUT, THAT WOULD NEVER HAVE OCCURRED. THAT IS WHY SO FEW PEOPLE REALLY MAKE MONEY IN THE MARKET. When this dropped to $1.62, a smart investor would have realized, nothing changed, except that the stock had less downside risk and greater upside. So sad.
3. Several things can kill the shorts:
a: any movement on RIGS, i.e. movement in Europe would kill the shorts
b: CAH deciding to make a play on the company if NDA is approved to save itself some money from waiting to see if future approval takes place. (This is unlikely, since companies usually prefer a bird in the hand than two in the bush. But you never know.....)
c: they can buy another company who needs some marginal financing to be approved and add to their future revenue stream. (This can also hurt ST, as people question synergies and future success.)
d: NDA approval without advisory panel or with some sort of expedited review. Remember, this product has demonstrated enough superiority that FDA could say "we need this on the market sooner." Again, unlikely, but who knows?
e: Large investor decides to invest in the company demonstrating good faith in it's future. Anyone know carl icahn's phone number? You get the point.
Finally, for those who say NDA acceptance and FDA approval are two different things, you are correct. But in this case, it would likely mean the citizen's petition is out the window, and the comparison to VBD was a fair one. Also, if you care about stats, there is a greater correlation with FDA approval and NDA acceptance. (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm127153.htm)
And finally, big money has already placed its bets: http://ragingbull.quote.com/mboard/boards.cgi?board=NEOP&read=21684
Which side do you want to be on?
I don't doubt that after NDA acceptance, shorts will say SEEK won't be approved so who cares? Or that seek won't sell if approved? But unlike AVNR, who had to do it on their own, NEOP is asking the leader in the field to insure that seek will be successful. CAH is not some little joke company. My money is still on them........and on NEOP
P.S. Don't have time to get into Gekko. But I'll say this: In over 5 years of reading him, I find him to be fair. He was wrong about ALXA, right on AVNR. And many others wrong and right. I'm curious to see what he has to say? AF is much more suspect in my opinion. He usually shoots first and asks questions later. And Biomed reports is more for people who trade, rather than invest.
GLTY sts66 and GLTA
Also, remember that just 4 months ago, the total institutional % was under 3%. That's an incredible increase in a relatively short period of time. It tells me that those conferences were well run, and accomplished their goal--new investor infusion.
Prior to April, all we had were retail investors, including many day-traders. Now we have people who are REAL longs and more institutions. (Obviously you will always have some ST traders and flippers, but those numbers are significantly down.)
Short's will continue to try to pound this b/c MOST biotech stocks fail, and you can always go the 2nd angle if the first fails: 1st angle: trial was done wrong, i.e. delay or CRL; 2nd angle: even if approved, revenues will be significantly lower and thus PPS still deserves to be $2.
They did that with AVNR, they'll do it here too. But there are some big differences here. CAH could opt to put an offer for the whole company at any time (although likely after seek approval to minimize risk). Rigs movement, any movement, could hurt shorts greatly. Greater institutional involvement leaves less room for manipulation. Blackout period ending allows insiders to show their support for company with their $$$. Drug gets expedited review/approval, and/or no advisory panel. CP gets thrown out the window. The risk/reward has changed. At $2.35, it makes MORE sense now to go long than short. And that is the bottom line.
I'm reposting what I wrote earlier, b/c I know there will be people wondering about how long before nda acceptance, pdufa, and whether advisory panels are needed or not.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=64403872
The remarkable increase in institutional holdings should tell people where this stock is truly headed. Also, now that NDA has been filed, I believe the blackout period for insiders to buy will be over. You will see some insider buying (if it hasn't already occurred, immediately post NDA submission.)
Any rigs movement will likely be an added boon so August 15th will be a significant date. FDA acceptance of NDA and concurrent rejection of CP will boost PPS as well. Shorts have only started to cover. Plenty still out there. But the last couple days have shown what institutional buying and/or insider buying (potentially but not likely yet) can do to move the PPS. Shorts manipulated this down well. But now I look for them to get the same wrath in return.
The day rigs spa is announced, we could see $7, forget about $3, 4 or 5. And next week we will have a better understanding of when that will occur.
Most retail investors are long gone, but if we go back to mid $3's I think you will see some swing players return; we shall see.
Last few days was likely institutions buying before NDA was announced. And you saw the other day what it took to go from 2.05 to 2.70--about 15 minutes. (Too bad I bought 1000 of those shares at 2.70. But if I liked this at $5, $2.70 must be a steal.)
We only had 1 real milestone that they hit before--listing on AMEX. But this one is a really big one. We have a study with great efficacy and safety. But shorts will say that even if approved, this will go nowhere. Revenues will be weak, they will say. I think that will sound different when CAH starts talking in the near future. And by the time seek starts getting marketed, RIGS WILL be in motion, so that could counter any negative short pressure.
Well....there still is the acceptance, pdufa, and hopefully approval. But what will the shorts do if advisory panel is NOT needed. I'll get the frying pan, and we can start frying.....
GLTA. My portfolio has seen its share of ugly. But I can live with whatever result we get. This company has better management and two great products. If it were a slam dunk we'd already be at $10. But if you want to make real money, be patient. The madness has only begun.......GLTA
Just wanted to mention something while it's on my mind. I think NEOP needs to partner to really make RIGS work out. Having seen how hard it was to get seek to the table, and having heard BUPP say a 100 times that they WOULD partner, I believe this to be true.
So..........as I mentioned months ago, who do they partner with? If CAH, then they become a mini CAH company and people eventually will expect a buyout. If they choose covidien, it may piss of CAH whom they need to promote seek. It's a tough spot. And so the answer is likely that they do choose CAH.
So how do you get a better deal, if CAH knows that it should be them? You get $30-50 million in the bank to show everyone that you're serious enough to do it on your own. And if you're CAH, and seek is starting to sell well, and you have several former executives on NEOP's board, you make a sweet deal to partner for rigs or consider an all-out buyout.
Now, this would likely not occur until 2013---yes 2013, b/c pdufa will probably be september 2012 assuming all goes well. So earnings really don't come in until QIV 2012. But the point is, that is why they are doing this now.
The proposed shelf was likely in case they wanted to increase their pipeline, to look more desirable to partner as well. But having seen PPS erode, that is likely off the table now. (Remember, they could have done an offering before as well but chose not too. These guys ARE cognizant of PPS--why else would they have responded with a PR Monday or a PR against Shrek?)
Just thought we'd discuss something else besides irrelevant articles and PPS below $2.80. Remember, we started the year barely above $2. That won't make me feel better about the 4000 shares I bought between 4.75 and 4.99. But it will put things in perspective, something we all lose when things shoot up...or down.
Neop released the 2010 annual report: http://neoprobe.com/annualreports/2010AnnualReport.pdf
There it is, courtesy of DDbuyer.
Some interesting things of note:
"During 2010, and to date in 2011, we achieved a number of commercial and research milestones
including:
• Completion of our Phase 3 NEO3-09 clinical evaluation of Lymphoseek®, Neoprobe’s second
Phase 3 study in subjects with breast cancer or melanoma, which demonstrated superior
performance of Lymphoseek compared to the commonly used vital blue dyes;
• Completion of two successful meetings with FDA to support a New Drug Application (NDA)
submission for Lymphoseek as a lymphatic tissue tracing agent;
• Completion of a successful meeting with FDA focused on manufacturing to establish a new
Investigational New Drug (IND) application for the RIGScan™ technology;
• Introduction of enhanced product components for our gamma detection device systems;
• Record revenues and strong increases in product margins in our gamma detection device
business;
• Announcement of the planned sale of our device business to Devicor Medical Products;
• Listing on the NYSE Amex stock exchange, the premier trading platform for small companies;
and
• Addition of veteran staff to lead critical commercial and clinical functions."
Who says these guys aren't doing anything? Come on....
"In connection with the end-of-Phase 3 meeting held in March 2010 with FDA for NEO3-05, we also
engaged FDA about amending the design of our third Lymphoseek Phase 3 clinical trial (NEO3-06) in
order to specifically support claims aimed at sentinel node detection in subjects diagnosed with head and
neck squamous cell carcinoma. Claims for sentinel lymph node mapping are intended to have a very
specific focus distinct from claims for more generalized lymphatic mapping and anatomic delineation of
lymphatic tissue."
"The potential interim analysis of the clinical data from
the NEO3-06 study may occur by the end of 2011."
Another milestone coming up....
"With the guidance gained from the pre-IND meeting, we intend to work with FDA and the European regulatory
body (EMA) to receive clearance to initiate clinical evaluation of RIGScan in 2012."
Although far from coming to fruition, RIGS will get moving within a year's time. Watch out shorts. Martin, that means you specifically since you admitted to not having even calculated the potential for RIGS in your well thought-out (cough) analysis.
"In June 2011, we hired Dr. Thom Tulip as Executive Vice President and Chief Business Officer. Dr. Tulip
is a 25-year veteran of the radiopharmaceutical industry with extensive experience in developing and
commercializing radiopharmaceutical products both in the US and internationally. Dr. Tulip is responsible
for expanding the Lymphoseek commercial opportunity, seeking potential RIGScan partnerships, and
expanding the Company’s pipeline."
Look for a partner for RIGS in 2012, once things start to move. And money from sale of device unit was likely to aid in helping NEOP acquire a future company to expand their product line. This sounds more like a short term negative but positive long term gain. Acquiring a company or drug would put some strain on their balance sheet and/or manpower. Perhaps that is why the shelf was proposed. But seeing what's gone on with the PPS of its own stock, I think NEOP will try to get seek approved before any grandeous thoughts of acquiring anything occur. IMO.
"In addition to augmenting our internal staff, we enhanced our Board of Directors with the July 2010
additions of Brendan Ford and Dr. Eric Rowinsky as members. Mr. Ford brings significant business
development expertise from his years as head of corporate development at Cardinal Health."
Eventually, a buyout will be on the table. Too much overlap between NEOP and CAH. How this plays out with RIGS partnership is anyone's guess? Can't partner with covidien without upsetting CAH. Partner with CAH and who elso would buy the company? Would NEOP garner a fair price?
And finally.......no mention of anything regarding ACT. I guess seek and RIGS have them plenty occupied, for now.
I think the points you guys make are all valid. But the big point is still sometimes overlooked. The stock is $2.40. And that is ONLY because people now fear that another trial MAY be necessary. I know seek is better. It's safer, more efficacious. That's not the point. If the FDA will make NEOP do another study, you're looking at about a 2 year delay and a stock going to $1.
Now then.....having said that. I have 15,000 shares and picked up another 1,000 yesterday AH at 2.41. So you see where I stand. If you think the shorts are right, sell now. It will go lower. If you think that NEOP files an NDA and FDA will approve and throw out CP, then back up the truck. You'll see a 100% gain before the EOY.
I know SC was only approved for breast cancer. But it still throws out part of the argument before, which said that NEOP had to run the study against VBD b/c SC was not FDA approved. Also, now it may mean more competition, b/c some doctors will be reluctant to change. They can now get more $$$ using SC and have to wait 1 year for seek to be approved. That's still an unfortunate lag time for NEOP, even if their product IS superior--it is.
Could you conduct a trial using both versus seek? Not sure? I got what you said. And it makes sense. But why not do seek vs. current standard of care (VBD and SC) and just base results based on safety and efficacy without separating which agent was the problem? That likely could be done.
The FDA told them to do it this way and they did. But the FDA is a wild card that can never be predicted. In the end, I think all your points are valid and seek will go through on the first pass. But EVERYTHING now comes down to will FDA accept NDA (meaning throw out CP) or not and will they approve without seeing any further trials. That's really the ONLY reason we are at $2.40.
If you think things will still work out, do like me, and keep adding. But things are not quite as rosy as they were a week ago. It's hard to see that this has materially changed much. In many ways, practically it hasn't. But psychologically and competitively it certainly has.
By the way, NEOP could file NDA without going public about it. I can provide the link to show you guys if you care. But have to eat dinner now......GL everyone. But know that this is not a one-sided affair. Both sides have some legit claims. It's a matter of where you stand? I'm about 16,000 shares long.
And last thing---I can't go through all the positives and negatives. I'm certainly no DDbuyer. But I think the analysis and comments I've posted are fair, no matter where you stand, long or short.
Just ask yourselves why this stock will trade around $2 now? Something MUST have changed.
Much has been said about whether this news is good or bad and how it will effect things further out. I have been a LONG for sometime (full disclosure). Here is my take:
1. NEOP likely did NOT know about this approval. That is because the company is a private one, and did not have to file the NDA openly with FDA. (NEOP could also file under the radar, but I cannot think of any public comopany who would do so. The FDA does not post NDA's on their website. My prior posts go into this further.) Second, they performed a meta-analysis. That means they looked at all the literature and then narrowed it down to the BEST criteria to see if SC was significantly better than VBD. I could do the same thing by just spending a good amount of time on pubmed. So the fact that this comes as a surprise to NEOP IS UNDERSTANDABLE. (Although in retrospect, what would you do if you had a product that was the current standard of care, but may become obsolete if SEEK is approved? You'd try to make that more marketable wouldn't you. Hence Pharma's tactic.)
2. There's nothing on FDA or pharma site that says that it was approved. So what? No one says they have to update things immediately. Until proven otherwise, we can only speculate; but it seems prudent that the FDA WOULD approve an agent with so much success in the literature, that is the current standard of care DESPITE having some serious complications/side effects, including anaphylactic shock.
3. This is good news for NEOP. Yes and No. The good is that in some ways it validates their Phase III study. But in other ways it is bad. There will be people supporting Shrkeli's thesis that they should compare seek to VBD and SC, now that both are approved, especially since VBD and SC were standard of care even before yesterday's announcement. Second, that means that a new trial MAY be wanted by FDA. If you can't see this, then you must now, having seen the stock drop to 2.40. This is the REAL CRUX OF THE PROBLEM FOR NEOP. If seek gets pushed out this could really kill the stock short term.
4. Management sucks. No, prior management sucked. Current IS getting things done. They listed on amex and will shortly file NDA. If they responded to Shrkeli--rare to see any company answer a short's petition--you can bet they will put out a PR Monday about this.
5. Doesn't matter, seek will be approved. Not so fast. FDA is FDA. No one knows what these guys will do. If it does approve, CAH will still have to make others realize this is the better way to go. While they can say it's more efficacious and has less side effects, it will be a harder sell since doctors can now stay with current standard of care and get reimbursed better. So superiority really does come into play. We'll see how it goes...
6. Nothing has changed. False. Everything has changed. The stock has gone from $5.48 to $2.40 in less than two months. Now there is a chance FDA may want another study (although I think unlikely). They are now competing with something (SC) that also is approved by FDA. NDA still not submitted yet. Retail investors may be gone for good. This last point is important. Those hurt from stock crashes in 1999-2000 and 2007-2008 have not returned. Do you think NEOP investors will return? They all see this as dead money. And it may be for now. Or.............
NDA is submitted and citizen's petition is thrown out. FDA accepts NDA and gives PDUFA. That could help stock out.
RIGS partnership announced, helping neop longs.
CAH decides that now that stock is so depressed, it may be feasible to buy company out for $5 and take the gamble on seek themselves. Unlikely but plausible.
So to conclude. Much HAS changed. In the end, if seek is vindicated and approved, we go much higher. But the analysts estimates will still have problems achieving their heights. Why? Because if it is approved, shorts will move back in. The next argument will be that doctors won't want to switch to seek when VBD and SC are working out fine and both are FDA approved.
So they will argue seek will get revenue for NEOP but maybe only $100 million or $50 million. Only time will tell. I bought 1000 shares at $2.41 Monday, because I do believe this was overdone. But I also do believe we could go lower. But I'lll leave the prognosticating to others---there's no shortage of people willing to comply, especially on YHOO MB.
Anyway, things aren't as rosy. But I still believe the end result will be good. It will be harder to get there without the retail investor. But look for institutions to get on board now that the price got cheaper. And look for a Monday PR from company. But now I realize again, that nothing is ever a slam dunk. Hope neop is speaking to FDA Monday in the hopes of getting this moving quicker to our ultimate goal. Hope the company does some damage control. They need to. And even if this approval was only for breast cancer, it doesn't change the fact that it's now all about whether Martin was right---if another trial is needed, watch out. If not, load up the truck.
GLTA
I thought this was an interesting thread from yahoo board.
Here is the link to what I wrote in response to neo's original post.
See what you guys think?
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_N/threadview?m=tm&bn=123114&tid=22345&mid=22375&tof=1&rt=2&frt=2&off=1
I wanted to spend some time going over a few points, b/c I think it is important. The recent slide in PPS was primarily driven by a handful of factors (IMO): 1. Negative news (for first time in months) caused many retail investors to panic. 2. Some with significant profits took money off the table. 3. Daytraders and swing investors were forced to take losses either due to margin calls, or on their own seeing their investments plummet. 4. Bupp selling at an inopportune time. 5. Necessary correction after overextension of PPS. 6. Possible manipulation (i.e. naked short selling....etc.) I list this last b/c it is the least likely, we have no proof, and I rarely believe in conspiracies. Period.
Since the Yahoo board has turned to waste, I'll begin over here:
Since most retail investors have been burned, this is the group that needs to realize what is REALLY going on here.
First and foremost: THE MARKET IS IRRATIONAL. This shouldn't come as a surprise to anyone investing for some time now. Was nasdaq overbought when it hit 5000? You betcha. Was the dow oversold in 2007/2008. Yes again. Markets CANNOT be expected to be rational. For two main reasons: they reflect what PEOPLE are willing to pay for securities, and we are always at least somewhat emotional, thus potentially irrational. And you could never make or lose $$$ if everything was aptly priced. NEOP at $5.48 was certainly a little ahead of itself. And at this time next year that price will be certainly BEHIND its potential. When I see posts like this, I find it silly how little people realize:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_N/threadview?m=tm&bn=123114&tid=18603&mid=18603&tof=32&frt=1
The stock was 5 cents less than 10 years ago. It was $2 in January. It's now $3.62. What's wrong with that? Now to be fair, all the points this poster laid out are fairly correct. But the mistake he makes is that he correlates the decline to one piece of literary garbage. Similarly he thinks that all those good points, like a solid phase III experiment happened overnight. Where was the PPS when that phase III started? It's ridiculous how shortsighted some can become when the mood turns sour.
As for the shorts.......They are NOT going away. Neither is our boy Marty. Why?
If he shorted prior to his piece, then he's already made good $$$, whether it's his or his hedge funds or his friends. (Feel free to substitute the word crooks for friends if you prefer.) He has taken a great deal of time to write this petition. At the least, he has shown resolve, no matter how wrong he is---I believe his is very wrong, and will be proven so in due time. If he can still hate this below $4, he will hate it more when we see $5, $6 and $7. So he, and others will continue to short. Further, most biotechs fail, so shorting them IS USUALLY profitable. Even if they pass, shorts often persist to drive down PPS so that they can exit their position. (Take a look at AVNR....shorts remain thinking drug will prove to be useless.) And finally, some small biotech stocks can literally be destroyed by shorts if sentiment drops sharply. The bottom line is shorts play dirty.
Nothing is a given in biotechland. This company has at least 2 great products. But some questions will persist. I've said this many a time before.......everything in life (and investing) is perspective. Two people lose their legs in an accident. One says......That's it, I'll never walk again. My life is over. The other says, I'm just glad to be alive. Both are right. But which do YOU subscribe to?
http://www.nasdaq.com/asp/holdings.asp?symbol=NEOP&selected=NEOP&FormType=Institutional
Do things stink b/c institutional ownership is so low? Or is it great to see so many new companies adding to their positions in NEOP. With all the PPS decline, did ANY institutions SELL? Better click that link again. There's a lot of room for more people/funds to join the party. Spread the word.
What about Marty's claims?
http://www.investorvillage.com/groups.asp?mb=16085&mn=7075&pt=msg&mid=10620962
FDA can always change their mind. They sometimes do. But you have to believe that these issues have ALREADY been dealt with when they sat down with NEOP to design the latest completed trial. Why would CAH agree to a deal with this company? Why were they confident enough to sell their devices unit? After two stellar phase III trials is it likely the FDA would ask for another....again?
What effect will the petition have on this process? I don't know. All the research I've found involves citizen's petitions with ANDA's not NDA's. But this is interesting:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2011/06/fda-issues-final-505q-citizen-petition-guidance-says-certificationverification-statement-accuracy-is.html
Last paragraph from the above link:
"And while we’re on the topic of citizen petitions, we note that the U.S. District Court for the Eastern District of Pennsylvania recently issued an opinion in In Re Flonase Antitrust Litigation. The case stems from three different lawsuits filed by various parties alleging that GlaxoSmithKline (“GSK”) violated the antitrust laws by submitting sham citizen petitions to FDA pre-FDAAA and initiating a baseless lawsuit challenging FDA’s approval of generic FLONASE (fluticasone propionate) Nasal Spray. (As we previously reported, last year the district court denied GSK’s motion to dismiss.) GSK moved for summary judgment, arguing that its conduct is protected from antitrust liability under the First Amendment and by the Noerr-Pennington doctrine, under which private entities are immune from antitrust liability in petitioning the government to influence the passage or enforcement of laws, even if the laws they advocate for would have anticompetitive effects. Judge Anita B. Brody denied GSK’s motion for summary judgment, saying that “genuine issues of fact remain as to whether GSK’s conduct was objectively baseless, and thus constitutes ‘sham’ petitioning not entitled to Noerr-Pennington immunity.”
Interesting....................
And as for Bupp being a jerk.........He did screw many things up. And his selling shares did further help to kill the PPS recently. But where would this company be without his loan? Why did he stop selling shares now?
The price was inflated, so he chose to sell. He needs money for whatever lifestyle he so chooses, and perhaps to purchase more future warrants:
"In July 2007, David C. Bupp, our then-current President and CEO, and certain members of his family (the Bupp Investors) purchased a $1.0 million convertible note (the Bupp Note) and warrants. The Bupp Note bore interest at 10% per annum, had an original term of one year and was repayable in whole or in part with no penalty. The note was convertible, at the option of the Bupp Investors, into shares of our common stock at a price of $0.31 per share. As part of this transaction, we issued the Bupp Investors Series V warrants to purchase 500,000 shares of our common stock at an exercise price of $0.31 per share, expiring in July 2012."
Above taken from page 27, latest 10 Q....link: http://www.sec.gov/Archives/edgar/data/810509/000114420411027743/v221640_10q.htm
As for future movements in price.........I don't profess to have a clue. Neither do any of you. Will NDA move the stock? Likely yes, but who really knows. It usually does for most biotechs. After all, it costs $1.5M just to submit. But who knows. This much I do know.......several positive things are around the corner.
These are both likely in July: possible grant and NDA submission.
http://www.investorvillage.com/groups.asp?mb=16085&pt=msg&mn=6300
According to Bupp, 45 days after results (May 3rd) is the approximate time for NDA filing. Now, b/c of petition, perhaps they are taking more time to dot the "i's" and cross the "t's." But either way, I think it is HIGHLY likely that we will see this before August.
I could go on, but I'll leave you with two last comments:
1. From page 7 of year end 10K: http://www.sec.gov/Archives/edgar/data/810509/000114420411015182/v214630_10k.htm
"FDA indicated that the clinical data from the NEO3-05 clinical study and other completed clinical evaluations of Lymphoseek would be supportive of a NDA submission for Lymphoseek. FDA also encouraged Neoprobe to request a series of pre-NDA meetings to review the non-clinical and chemistry, manufacturing and control (CMC) components of the NDA prior to its formal submission. Neoprobe completed successful non-clinical and CMC pre-NDA reviews with FDA during the second quarter of 2010.
As a result of the March 2010 meeting, we moved forward with a plan to file the NDA for Lymphoseek later in 2010. A key part of the plan, however, was to ensure that the patient population in the safety database that would be considered in the approval of Lymphoseek would be adequate to meet the expectations of FDA. As such, in July 2010, Neoprobe initiated enrollment in another Phase 3 clinical evaluation of Lymphoseek in subjects with either breast cancer or melanoma (NEO3-09) which we expected would accrue patients, primarily for purposes of augmenting the safety population and to support expanded product labeling claims. Based on guidance received in the March 2010 meeting, we planned to file data related to the NEO3-09 trial as part of a planned major amendment to the primary NDA.
In October 2010, Neoprobe met with FDA for a pre-NDA assessment for Lymphoseek. As a result of the pre-NDA assessment, FDA requested that data from both the completed NEO3-05 study and the NEO3-09 study currently in progress be included in the Company’s primary NDA for Lymphoseek rather than submitting the NEO3-09 study safety data as a planned major amendment to the ongoing NDA review, as initially intended. The pre-NDA assessment resulted in no modification to the NEO3-09 trial design or endpoints or to any of the other previously agreed-to clinical or regulatory components of the Lymphoseek NDA. As such, NEO3-09 will now be one of two adequate and well-controlled trials included in the primary NDA submission for a first-cycle review.
In February 2011, we announced that we had enrolled an adequate number of subjects to enable us to meet the lymph node accrual goal for the NEO3-09 clinical trial. Preliminary top-line data are expected to be announced in the second quarter of 2011. In addition, the results of the NEO3-09 clinical study may support the inclusion of enhanced product claims for Lymphoseek in the primary NDA submission.
The Lymphoseek NDA submission will be based on the clinical results of the Phase 3 clinical studies NEO3-05 and NEO3-09, and other already completed clinical evaluations of Lymphoseek. The request for the total data package from two Phase 3 clinical trials is consistent with FDA’s ongoing initiative to push for more complete primary submissions and to limit major amendments made to NDAs. This ongoing initiative to shorten drug review cycle times was re-emphasized by FDA’s Office of New Drug Development in late 2009 and enables more successful first-cycle reviews which ultimately shortens overall drug approval timelines. We believe inclusion of the NEO3-09 study data in the primary NDA submission may support stronger product labeling as an outcome of a first-cycle review of the Lymphoseek NDA and may also positively impact market adoption.
We plan to use the safety and efficacy results from the NEO3-06 Phase 3 clinical evaluations of Lymphoseek, which will include sites in the EU, to support the drug registration application process in the EU through the centralized drug authority EMA as well as to amend the filing in the U.S. for expanded product labeling."
And finally......sometimes you will make money in stocks, other times you will lose. But if you do your due diligence.......you will always sleep well at night.
Sleep well my friends, July is just around the corner.
New figures:
http://www.amex.com/amextrader/tradingData/amexShortInt/AmexShortInterest.jsp
There used to be a time shorty was getting hammered. Not so much these days. But several things are interesting to note:
1. Last two months have seen a continual increase in shorts.
2. It does NOT appear that the shorts are covering.....yet.
3. Short interest is now a significant statistic comprising about 10% of float
4. In 6 weeks, 3 million new shorts were added, a significant amount.
You guys decide what it means, if anything. But one thing is for sure, battle lines are beginning to take shape.
I guess we would expect that as we are heading towards the home stretch.
Have a good weekend everyone. You too.....Mikevestit
"Whatever happened to fundamentals?"
Are you serious? Do you think 80% of biotech stocks trade based on fundamentals? If you want to vent, use some sense. This stock---like many other small biotech stocks---trades on future earnings, or pipeline. Forget fundamentals......
We can talk about that in 2015 when both seek and rigs are approved and revenue is coming in. But by then, this will be called Cardinal Health.
I don't think anyone believes that the downtrend had anything to do with fundamentals? It was a mini bear attack solely begun by a shrewd, or perhaps clumsy manipulator. (Clumsy, if he pays the price for his actions. We shall see...) Shrkeli's sole intention was to hurt the stock. Because it ran from $2 to $5.48 (since January) many people were in it on margin alone. Between their margin calls and other longs afraid to lose their profits, the stock began to tank. Bupps selling at this most inopportune time further exacerbated the damage.
If you want fundamentals, go to the banking sector. Biotechs may not be for you.
Slamming a guy is often worthless. But if that guy committed a criminal act, and the message gets heard, and he IS prosecuted......perhaps it is NOT so silly. Wall street is highly corrupt. It's never bad to go after someone who has caused so much harm to others.....even if that harm was only $$$.
Otherwise, you might as well let Madoff go back to his home. What this guy did reeks of stench. The story is only beginning to come together. And this is no conspiracy theory, mind you.
"Agree having a SPA is almost a guarantee for approval."
Well.......sort of.........
http://seekingalpha.com/article/235470-3-upcoming-fda-decisions-to-watch-closely
At the end of the day, FDA still has a few outs. Look at their site for exact details. It's listed there.
Also, SPA does take more time and usually money to do. However, if I had to choose, I would agree that an SPA is a better way to go. But primary endpoints still must be met, and FDA still can say...whoops, we want more information.
That's fair. But how about the other example? AVNR got rejected and then resubmitted NDA. 4 years later they got a PDUFA without an advisory panel and got approved. However.....they did have an spa with the fda.
So perhaps that is the real key. If RIGS gets an SPA, perhaps no panel would be necessary. But seek likely WOULD need a panel prior to PDUFA. Just the fact that the analyst asked Bupp that question, however, makes me wonder if there aren't other examples out there. It's just that I haven't come across any yet. But I'm really only familiar with about 30 biotech stocks.
I'll keep looking......
Russell 3000....
Ok it is midnight. But last thing:
http://premiacap.com/QWAFAFEW/hass_20030424.pdf
From what I gather, there appears to be a slight runup PRIOR to inclusion in Russ3000 for most stocks. Seems like that lasts about a month, and then things come back DOWN to normal. Since there has been so much confusion on yahoo about this, I thought I'd include that link.
Seems like short term, it definitely helps. But long term, it may be more of a wash. Although....at this point, I'll take any help we can get.
P.S. Daddy Fat Saxx thanks for the kind reply. I can't reply privately, or I would have. Good luck to all......
Happy Father's Day to all. I managed to do some research this weekend that I wanted to share. I've posted some of this before on yahoo or raging bull. Some of it, is new to me. It may be prudent. I'll let you all decide.
http://www.gekkowire.com/?p=7305
Interesting article, I thought. May be a better way to fight the shorts. Have women with breast cancer explain how painful it is to use current treatment methods to help FDA realize there is a NEED for this drug. I feel this is a very important thing to do---although AVNR did not do this, to the best of my knowledge, I am convinced it helped them get THEIR drug approved. (There was no drug to treat PBA, and whether you think the market is small or large, the FDA wants to help people who cry or laugh uncontrollably--there was a definite need.)
http://www.rxlist.com/cis-sulfur-colloid-drug.htm
As to your question about NDA's, advisory panels, etc. That was a more complex one. Here's what I found:
"'In summary,' the preamble stated, 'FDA believes that the primary goal of the advisory committee (and outside consultant) system should be to help the agency make sound decisions based upon the reasoned application of good science.'"
http://www.nap.edu/openbook.php?record_id=2073&page=89
Taken from the same document, but page before (page 88):
"The preamble also stated that advisory committees "generally" advise the Commissioner on the "safety and effectiveness and regulatory control of human prescription drugs," including "whether the available information is adequate to support a determination that a particular drug meets the statutory standards for proof of safety and effectiveness necessary for marketing approval." At the FDA's request, such committees review "certain critical studies or critical elements of studies on drug products under consideration and labeling issues"; they also respond to specific FDA questions that ask them to identify ''the adequate and well-controlled studies which demonstrate effectiveness, the seriousness of certain adverse effects, and whether additional studies or data are necessary before a decision can be reached.''
The FDA identified the following as high-priority items on which it sought advice from advisory committees:
drugs subject to active IND's and pending NDA's that offer potential therapeutic advances, that pose significant safety hazards, that present narrow benefit/risk considerations, that have novel delivery systems or formulations, that are the subject of a major scientific or public controversy, or that are the subject of special regulatory requirements, such as a limitation on clinical trials, a patient follow-up requirement, postmarketing studies, or boxed warnings."
As to your question do some companies get NDA with no panel? Yes.....DNDN for example....
http://www.thestreet.com/story/10692811/dendreon-wont-face-second-fda-panel-biobuzz.html
http://blogs.forbes.com/sciencebiz/2010/03/02/no-panel-for-provenge/?boxes=businesschannelsections
Incidentally, Favus wrote a negative research report that killed DNDN and did the same to AVNR, allowing for its short interest to peak at 26% two day prior to their PDUFA.
http://www.thestreet.com/story/10901249/1/avanir-the-short-and-long-of-avp-923.html
OK.....I'm still annoyed with that blatant bear raid/manipulation. But I'll try to stay on topic.
Usually NDA's will get advisory panels for the reasons listed above. Based on what I'm seeing, RIGS would actually have a better chance to NOT have one. Since it does now have long term survival data, an SPA with the FDA could insure that no panel would be necessary. However, depending on how the biologic is produced, they may still want to convene a panel.
Your question, however, pertains to seek. Will IT get an advisory panel? If I had to guess, I'd say that likely the answer is yes. However, that would not by any means signify a negative event. Rather, the FDA might want to do so b/c this is so significant an event, in that they will be deciding on not just approval but superiority.
Another good read on this topic:
http://lifesciencedigest.com/2011/02/06/fda-advisory-panels-no-means-no-yes-means-maybe/
I know many of you have gone to sleep by now....but there's some more good info here. Read page 3 of this next link. Perhaps we can get DDbuyer to pull the trigger on this one, if a panel is indeed convened:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM236144.pdf
And finally:
1. NDA submitted
2. 60 days later the FDA decides if they will accept the NDA submission as complete or tell the company the NDA is not acceptable
3. If the NDA is acceptable, then the FDA decides whether or not a drug receives priority review or standard review
4. A PDUFA date is then set by the FDA based on which review process the drug gets, if the drug is a priority review the PDUFA is usually set around 6 months out, if it is a “standard review” then the PDUFA is set further out to about 10 months- this is the case with Cell Therapeutics
5. After the PDUFA date is set the FDA begins the review of the drug
6. If the drug data is strong enough then in most cases the FDA then decides on a DATE to convene an Advisory Committee to gather advice on whether the drug should be approved or not approved. If the data is weak, the FDA can simply issue a complete response letter at this step at any time. If this happens the company is usually asked to run another clinical trial, this would be the worst case scenario at this point (In fact, this just happened to HemispherX). Another scenario that could happen is that the FDA decides it does not need to convene an advisory panel and simply decides to approve the drug (keep in mind this is a very rare occurrence, I have seen this twice in my life, so the likelihood that this will happen is slim).
7. In setting the Advisory Committee Panel meeting date it is helpful to know that the advisory committee usually meets somewhere around 1-4 months before the PDUFA date to cast a panel vote on whether the drug should be approved or not.
8. The company then meets with the Advisory Committee Panel on the set date to answer questions about the drug
9. The Advisory Committee Panel casts a vote on whether the FDA should approve the drug’s NDA or not
10. After the advisory panel votes and gives the FDA its recommendation the FDA usually waits until the PDUFA date to inform the company whether or not the NDA is approvable in its current form or if the drug is not yet ready to be approved (For an example, Vion met with the FDA September 1, 2009 for a panel vote and was told by the advisory panel that the drug needs to be tested in another clinical trial. However, the PDUFA date is not until December 12, 2009, so the FDA’s official approval or non-approval has not been issued yet). cont’d next page
Here's the link : http://www.gekkowire.com/?p=1785
I found the same info on FDA website but this was more concise.
I'm not sure why I put all this out there? Anyone can get this information readily? I'm hoping that perhaps if we all pull together, we can make others realize that this company has a great future, this stock has great potential, and only the FDA can truly decide. But there seems to be some opportunity to counter what the shorts--or the short--have/has done.
I hope this provides some clarity. It's almost midnight. Tomorrow is another day.........GLTA
Thanks for the reply. I guess what we're both saying is those numbers don't tell the whole picture, but they do, perhaps, give us some sense of what's going on.
On a separate note.....I wanted to post some important points taken from the November CC. I think a lot of this has been overlooked:
"Caller: Suy Anne Martins – WBB Securities (Analyst)
Q – Requested feedback on relationship with FDA regarding Lymphoseek, and also asked about Superiority claims of Lymphoseek over Blue Dye
A (Bupp) – I think we’ve had a very good dialogue and relationship and interaction with the FDA. I think that was supported by the fact that the module reviews that we planned with the agency on both the non-clinical and CMC modules during the summer were in fact canceled at the request of the FDA because they felt that they were complete and accurate. Regarding the October 4th meeting, clearly the review division had agreed to, and it was part of our March (meeting) minutes that they did agree to a planned major amendment. Beginning around March 15th within FDA and with the new reporting structure of FDA they indicated that planned major amendments wanted to be avoided so that first cycle review could occur. Once we agreed to that and had the confirmation that there were no changes to the endpoints as designed on either NEO3-06 and most importantly on the (NEO3)09 study, and that they agreed with our statistical analysis plan and the opportunity, if the clinical data supported, that we could submit additional efficacy data that might support a superiority claim, the rest of the call was relatively short. And even that portion was not an extended discussion. The additional personnel within the hierarchy within the FDA participated in that call. So I feel very comfortable that we have a buy-in and a confirmation of the plan that we have for the FDA and the endpoints that we have outlined. As I indicated in my remarks the safety profile of Lymphoseek continues to be excellent with data to date.
A (Dr. Cope addressed Superiority claim portion of the question) - As you’re aware of the results of NEO3-05 and under the construct of NEO3-05 there was not a prospective construct in there relative to the Blue Dye, which was essentially the requisite comparator for the study where Blue Dye was compared against Lymphoseek. To the extent that we built the study essentially the same (as NEO3-05) overall, in terms of the primary outcome from NEO3-09, we also included prospectively in that study a contrast with the comparator Blue Dye in terms of evaluating the statistical significance between the performance of both of those agents, that is both Blue Dye and Lymphoseek. We anticipate that the study will fulfill that expectation. Obviously we don’t have data or review that data on an interim basis. Interim analysis is not built into that study but nevertheless; relative to our experience with NEO3-05 we constructed that study to acquire that superiority claim to Blue Dye. We’ll obviously see the outcome of that at the end. We will review that data when we have completed the compilation of the results."
My take: They did what the FDA asked them to do.
"Caller: John Nobles, Taglich Brothers (analyst)
Q – Referenced the October biotech conf, where Bupp raised the potential Lympho market to $450 million market and asked for elaboration on that increase.
A (Bupp) - Most of that market size is related to what we’ve seen within the U.S. markets because of the pricing changes that have occurred with Technesium. We’ve also begun to factor in some of the performance, not necessarily the Superiority claim at this point in time, but some of the feedback that we’ve clearly got from clinicians on the performance standards of Lymphoseek and what we think we can garner in terms of pricing. We’ve been working with our marketing/distribution partner (Cardinal Health) in terms of looking at modeling and what they would estimate would be commercial launch prices for Lymphoseek. One of the other things I failed to mention in my remarks but we are going to have the opportunity now with the NDA to include data from two Phase 4 follow up studies, one of which has now concluded with two-year follow up of patients that were in Phase II (Lympho trials). That’s giving us data in terms of morbidity, meaning incidence rates of nerve damage, lymphodema, from patients that went through the Lymphoseek biopsy. We will also be able to include data from the12-month follow up from the first Phase III study (NEO3-05), Breast & Melanoma study. That’s not part of the labeling, but that will be very important information we think to include in the package insert for the product as we get ready for commercial launch. As I said, had we gone with the original NDA submission that would not have been built into the NDA model but now we will have that opportunity as well. Those factors are contributing to the potential market size. The other contribution is that we’ve had some dialogue with parties particularly in the major Asian markets seeing the adoption of Sentinel Node Mapping. Japan is a market that until really April or May of this year, the Japanese Health Ministry did not recognize Sentinel Node Biopsy as a reimbursable procedure, and that has been another change that contributes to that market size."
My take: $450 million is certainly reasonable.
"Q – Can I assume that shortly after that point (Neoprobe) can file the NDA?
A (Bupp) – Yeah. We’re doing, as we indicated in the October call, what I would call rolling monitoring. As soon as a patient completes we’re sending our CRA’s out to audit that data and to complete it. There is a requirement for roughly a 27-days post-surgery, safety follow up telephone call to monitor for a safety event. That’s the last part of the Phase III trial. In the meantime all of the data, the tables, all the programming for the statistical analysis will be done. We’ll be in a position, from the time that we announce “Last patient in”, being able to announce top-line data 30-45 days post that. Then we’ll be doing the NDA submission 30 to 45 days after that."
My take: While they always delay, (and already have) perhaps just this once, they could file on time. Just give me QIII. Please.....
"Q – Asked about the insider buying window and if it will open up in the future.
A - (Bupp) – We’ve been in a blackout period. A lot of times there are activities that are not disclosed in the public domain that would preclude insiders from buying even if it’s not the normal financial blackout period. Insiders have been supporting the stock when available, and will probably continue to do that. "
My take: If they can buy, they may start to do so. But it's not always feasible.
"Caller: Andy Davis – private investor
Q – RE: Potential for FDA requiring Review Panel for Lymphoseek, asking Bupp the likelihood that FDA will decide bypass the panel, and asked him to take a stab at the probability
A (Bupp) – Under first cycle review, if there is going to be an Advisory Panel meeting it has to occur during that first cycle review. The agency normally reserves the decision making on a panel until after the NDA is submitted. So that decision has not been made yet. We will not know that absolutely until roughly thirty days after we submit the NDA. We are preparing for that because the lead-up to a panel is not an insignificant rehearsal and preparation event. In fact there was a preparation today on exactly that subject and we’ve been holding those meetings over the last 30 days. So we are already preparing for that. Would I be pleased if they decided not to have a panel? Yes, but we’re not going to sit here and wait for that decision. We’ll be prepared for whatever eventuality and whatever the agency’s decision is. "
My take: If no advisory panel, shorts will fry.
Here's a link to read the whole minutes. Remember, DD is transparency. It may not always be accurate, but it's the best thing we've got. Have a good weekend everyone. And Happy Father's day.
http://www.investorvillage.com/groups.asp?mb=16085&mn=4869&pt=msg&mid=9759364
I'm glad you brought this up because I have some questions about these numbers....
I'm assuming you got them from FINRA? Correct?
Well....two problems I have with all this supposed transparency.
1. When I look at their total volume numbers, it never equals what I get from Yahoo. I know Nasdaq counts a share bought and sold as 2 shares, versus some other exchanges that count it as one. But even if you double the volume you show, it doesn't approach the nearly 1 million shares that traded today.
2. I've tried to measure those numbers over a 2 week period to see if it accurately reflected short interest, when the 2 week numbers came out. It never does. Sometimes it's close, sometimes it is way off. I remember DDBuyer alluding to something similar when HE tried the same experiment.
So.......I guess what I'm saying is, do these numbers really mean anything?
Or should we wait for the "real" numbers to filter in every two weeks?
Transparency is only good, if it is accurate.............