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Nice entry point imo. I'm in.
CCME - I have been reading a lot about it and still not sure what to think. It's certainly not lacking drama.
PLX - Looks like just jokers with a website, not real analysts, but using terms as an analyst would.
PLX - it takes a lot more $ to execute a successful bear/cub raid at $9.50 a share. If they shorted 400k shares today, it cost them about $3.5M, which they will need to cover and likely cover higher upon approval. Come on halt, approval, and $13-$15/share!!!!!
OT: LOL!
PLX - they try to create fear and a big selloff. However, we all know how strong our DD is on PLX. Remember your DD, just like DEPO, AVNR, and the others.
PLX - the new 10K sealed the deal for me. The only hole I could shoot in PLX was the approval of the manufacturing facility. We now have a safe, effective drug, with an approved facility. We also have a partner who appears to be working well with PLX and won't pull an ABT on us. As we know, they have the PLX drug on their site, which we couldn't say for ABT (w/DEPO). The drug is also being used around the world already.
My thought is the facility inspection was the last piece the FDA needed to take care of. Based on all of our combined DD, I expect approval tomorrow or Friday with favorable labeling.
I'm long and holding all through PDUFA. Good luck to anyone holding!!
AMRN ($8.08) - has bounced off this support area several times.
APCVZ - completely agree. I only commented to inform of the great risk and likely outcome. I also wanted them to be clear they were buying a CVR, not a stock.
APCVZ (-70%) - like I said, be careful with this one. All you had to do is crunch some numbers and you would see that they would likely never meet the threshold. I hope no one on this board was in.
PLX ($9.60) - the expectation is next Friday for approval. If it comes early, great, if not, no worries.
Reminder: U.S. Markets closed on Monday for President's Day!!
Yeah, I don't really understand why the FDA doesn't have it all in their hands already.
DEPO - I have no plans until we get closer to the Serada catalyst.
DEPO - they are asking for evidence to demonstrate the clinical superiority. I think some people think this is a safety issue or the FDA is having 2nd thoughts or something. Based on the data we reviewed here, it was clinically superior, so now they just need to provide the data.
KV.A has a mind of its own...lol! Crazy
MNKD - not even a good chart play, imo. I see no indication of a reversal. Even playing charts, you have to look at the bigger picture, which was just described quite well. Good luck to you.
AMRN - I agree too. This one will just take some patience. Seems to bounce off the $8.00 area nicely.
OT: LOL!!
PLX ($9.27) Short Interest Increases by 7.38%
Current 6,001,200
Prior 5,588,700
Very nice addition. I would have to go elsewhere to get this data before. Would be nice to see daily short volume too...similar to how you can get it from shortsqueeze.com
Keep up the good work guys.
PLX - thanks for the info BFR! There are many drugs out there approved by the FDA with similiar warnings. Actually, there are many out there with much more serious warnings, yet still approved. Of course there are warnings, but this doesn't seem like anything to be worried about imo. It appears that most of the trial patients continued on after experiencing side-effects and no deaths were reported. I'm glad this topic came up and we looked into it, but I feel it will have little effect on approval. There are hundreds of patients around the world already using the drug and more who want/need it.
These dramas continue to provide excellent buying opportunities on the over-reaction dips.
APCVZ - be very careful with this one. You're not actually buying a stock, you're buying a Contingent Value Right (CVR). If they don't meet the CVR threshold on this next 10Q, they will be worthless. I took a quick look at the numbers and I don't think they will meet them, but who knows. Their 4th Q would have to about meet their first 3 Q's of 2010. Risky lotto here. Good luck.
I didn't even see that one out there on the FDA calendars anywhere. What a beast it was today! In looking at the FDA decisions due in February, there are only a couple. A PLX decision could very well come early. I don't usually think that, but Feb is really quiet, so it just might.
PLX ($10.07) - massive buy at $10 took out that 70k shares. Looking solid here.
NEOP - here's a link to my DD post from 12/12/10 on NEOP...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57667191&txt2find=neop
PLX - $heff, Dr. Frost is indeed diverting his investment and here is proof of that....
http://www.www.istockanalyst.com/article/viewarticle/articleid/4846485
2. Opko Health, Inc. (OPK: 3.86, -0.05): $3.85
Shares of this medical appliances & equipment company were acquired by 2 insiders:
CEO & Chairman Phillip Frost M.D. acquired 1,158,000 shares, paying $3.55 per share for a total amount of $4.11 million.
Vice Chairman & CTO Jane Hsiao, Ph.D acquired 200,000 shares, paying $3.55 per share for a total amount of $710,000.
This is the second week in a row that Opko Health has made our list. In a note I sent out to subscribers in October I mentioned,
"Dr. Frost has been nibbling on small quantities of Opko stock every few days since the start of this year. These purchases were done indirectly through Frost Gamma Investments Trust. This relatively young Miami based company that was founded in 2006 has several potential drugs in Phase II and Phase III trials. The company also develops medical devices, vaccines and ophthalmic imaging systems. Revenue at Opko has been rising over the last several quarters but the company is still unprofitable and at its current run rate could run out of cash in less than a year unless revenue ramps up significantly. The stock has been rising steadily throughout this year in lockstep with Dr. Frost's purchases.
The 73 year old Dr. Frost has had a distinguished career, serving as the CEO of IVAX Corporation from 1987 to 2006 before it was acquired by SINLetter portfolio holding Teva Pharmaceuticals (TEVA: 55.38, -0.32). He is currently the Vice-Chairman of Teva Pharmaceuticals (TEVA). He also serves on the boards of Northrop Grumman (NOC), Ladenburg Thalmann Financial Services (LTS) and Castle Brands amongst many others. I will definitely add OPK to my watch list for further research."
Mr. Frost's shares were acquired indirectly through Frost Gamma Investments Trust, of which Phillip Frost is the trustee. Ms. Jane's shares were acquired indirectly through Hsu Gamma Investment, L.P. Dr. Hsiao is the general partner of Hsu Gamma Investment.
P/E: N/A Forward P/E: N/A Industry P/E: 26.98
P/S: 34.25 Price/Book: 50.89 EV/EBITDA: -55.26
Market Cap: $983.12M Avg. Daily Volume: 492,369 52 Week Range: $
Not at this time. I was not too excited about the ABT dispute resolution being a catalyst, so I sold. However, there are more catalysts this year, which I will be excited about (i.e. Serada)and likely buy back in at some point.
I understand your frustration about being stopped out, then watching DEPO fly today. I would imagine most of us sold on approval and were a little sick watching it run today. However, that's the stock market for you. Time to focus on the next play and don't look back. PLX and HGSI are the two that I'm focused on right now.
PLX - saw someone flash a 70k share offer at 10...just a measly $700k...lol!
HGSI ($24.90) - looking great here. Reversal confirmed and PDUFA forthcoming!
DEPO ($8.87) - it's acting like the ABT dispute has been resolved and leaked or something. If you recall, that ABT info leaked somehow before. Just speculating here. Very interesting action indeed. I actually love DEPO for 2011!
PLX Manufacturing Answers from IR:
Hello,
I am doing some due diligence relating to PLX and have some questions. I see that they are working to expand their current production plant(s) and it will cost about $25M to complete. I have three questions:
1) Will Pfizer help them pay for this as part of their agreement/collaboration?
Yes, but only a nominal amount
2) Where do they stand with regards to the expansion? (i.e when will they be done?)
in 2012
3) If they are currently able to produce their lead candidate drug for 1,000 patients, how many new patients will they be able serve after the expansion?
About 50% of the Gaucher disease market - ~2500 patients
PLX - 1st resistance is $9.87, 2nd resistance is $9.98, 1st support is $9.59, 2nd support is $9.42.
Thanks for that info.
PLX - last two quarterly reports came out on Nov 13th and Aug 5th. Expecting the lastest one within the next two weeks (pre-PDUFA).
24 days until the FDA decision (a Friday).
PLX - I just e-mailed their IR with my questions about their manufacturing expansion plans. I'll let the board know what I find out.
OREX - I tried to get a short allocation yesterday and could not get a locate.
HGSI ($24.40) - I just added at $24.3899. I believe they will get approval from the FDA, I like the SPA, and the chart appears to have cofirmed reversal today (day 2). I'll be posting more DD on this one later.
A couple things I have learned during some of these prior PDUFA plays (e.g. POZN, AVNR, DEPO), is that during the drama (i.e. bear raids, shelf filings, partnership disputes), adding shares on the dips or on the plummet is the way to go....and holding your core shares too. I'm not going to lie, it's hard to do and it's painful watching it. However, if you are true to your DD and you get the approval, it's all worth it. I also found that you need to be prepared for anything and know what you plan to do if it happens. For example, now if there is a partnership dispute prior to approval, I'll know how to react vs. sitting there thinking, what the heck just happened and what should I do. For PLX, I want to be prepared for any possible drama, since the drama seems endless on these plays.