Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
OT: scams
Back in bubblemania (2000,2001) I followed quite a few scammy companies as a short.
REFR was a carbon copy of HEB. They started a long time ago with what they certainly thought could be a great product (a new type variable tint glass). Alas as years went by the efforts to make it practical kept failing. So they had to get financing. So they issued PRs. ...
You get the story, and the equivalence to HEB. It's almost looks like self-dillusion. They are so certain that they have IT that anything becomes justified.
OTOH, a company like CTIC is a different story. They start out with a "How can we take advantage of people" type attitude. They probably never cross the bright line like REFR did and HEB almost certainly has, but IMO they are even more morally wrong.
Of course none of this matters to investors.
Re DSCO news
It means that the FDA does not accept that DSCO can INSURE that what they manufacture is what they used in trial. They are not claiming that the product IS different or the trials are invalid.
Re: Skenkman, FDA delay?
The FDA is not allowed to say publicly what is going on, but HEB could. They could publish any and all communications with the FDA.
But they will not.
And you probably know why.
Do not expect to hear more on the CFS BLA for a long time.
re: DSCO
At what point will the DSCO followers catch on that the company has been somewhat less than forthcoming about the extent of the CMC issues on Suf.? Even now some yahoo on Yahoo! is posting that it's not over, DSCO can appeal.
Another case of a drug that may very well work, but because of small bio shortcuts is not getting through the FDA.
Now some good news!
I will now officially start the rumour that CTIC will buy DSCO.
Re: SPPI private placement investor logic
It is also quite reasonable to suspect that they were simply flipping the 3M shares (or as many as they could) and pocketing the warrents.
Anyway,I am back in with a few shares (after selling my other half yesterday PM). If the PPS doesn't jump too fast tommorow I might just ride until news. Still will sell immediately after good news (and buy soon after bad news).
I know you don't like the concept, but you might think about selling after the news and buying back in a day/week or so [unless tax issues rule this out].
BTW, wallstarb if you are around. Are you not net long now? You never stated precise numbers, but it seamed like you were fairly alpha neutral, then covered some shorts?
Re: Wallstarb, SPPI valuation points
I am not really arguing with you that the valuation is running on momentum, but I do disagree with your numbers.
They have 41M fully dilluted shares. The number was 32.6M at end of Q1 and they sold 5.87 shares+warrents in march and another 2.57 in June. That yields a market cap of about $300M.
On the balance sheet, the had about 50 cash at end of Q 1 (either by counting cash+marketable-debt or by current accounts, and in either case ignoring the non cash def. revenue liabilities). They got an additional 34M since Q1, and cash flow should be about nill. So I will say $80M in cash ($2/s).
I do like something in the nature of your play though. A big advantage is that if the drug does get approved you can sell the calls and keep the short open for the certain fallback to rationality over the next few days. I assume for most of us peasents (retail, like me) attempting to short immediately after the FDA decision would be useless.
Re: SPPI
The drug may very well be "crap" per Wallstarb's def (which is obviously the ability to generate income).
The ability of SPPI to turn it into something valuable depends on several things, LEAST of which is this FDA decision.
So, this move pre-post PDUFA is ABSURDLY overblown.
I sold off half my shares minutes ago to de-risk it, and feel that I am doing little more than playing along with the HEB'ettes in holding on to any remaining shares.
I do think the odds with the FDA are good (better than Wallstarb's numbers), and that's what tempts me to gamble.
But if I any hold shares through the decision I will with 100% certainty sell ASAP on a thumbs up (even after hours if possible).
I may very well buy back in later, as I do agree with you long term. But short term there is a complete disconnect between the stock price and the company prospects.
Short term this reminds me of GTCB a few months back. A overblown run-up based on an FDA decision, then a fall back once the speculators left town.
Re: SPPI valuation
Yes, my opinion is unchanged. To clarify:
. I like the stock very much. They are running break even with a solid balance sheet. They will have an easy improvement on earning with Fusilev expansion, this alone will justfy the present share price.
. I suspect (and recent activity is confirming) that the "idiot crowd" that is chasing HEB/CTIC type stocks is crawling on board. This will drive the PPS higher than it should be NOW. Depending on how high they drive it, I am certainly likely to sell.
The fact is, the upcoming PDFUA date is not a huge event for SPPI. The big hurdle for Zev is really market perception (the REAL market in clinics, not Wall Street). And you could take Zev and toss it out the window and I still have good long term hopes for them (I will certainly buy on CR).
As too selling, I will bet you right now that if approved SPPI will hit a high immediatly and drop afterwards. So yes, I will sell and buy back in later. It's possible that I will sell before the decision, but unlikely as I like the odds.
Best of luck
Re: "What the hell is Ampligen"
. It is W Carter's (HEB's ceo) science project from the 70's.
. Per HEB, it is a wonder drug that can cure disases never seen before.
. It is likely the record holder for going winless in clinical trials.
To be honest, the FDA made a mistake here. They should have called an AC committee on this one just to kill this scam publicaly.
[OT] More on that Sahara solar stuff
How does the construction cost compare?
The EU energy budget for 2030 is estimated at 75,000,000,000,000,000 btu a year. The project claims to provide 15% of this. The only comp I have is that 3rd G nuclear is claiming 1000$/kwh construction cost ($1 per watt)
So to convert :
75,000,000,000,000,000/500,000,000,000 = 150,000 BTUxY/$
150,000 BTUxY = 150.000/(24*365) BTUxH = 15 BTUxH
15 BTUxH = 5 watt-hr
So we are talking 1/5 what the Nuke guys are talking.
Obviously they will not do an initial build-out of this to anywhere near full scale.
And also, anybody who believes these numbers probably invests in HEB and CTIC.
The reality is there will a huge initial cost to construct the infra-infrastructure (I just made this word up). Obviously they will want taxpayers to help out.
Medchal, on that solar project
First, you are correct that the 2800 number is BS. I did a quick check and it is (to within an order of magnitude) the total solar energy hitting Earth divided by our present energy usage.
But back to reality, why would you say the project is "dirty"? Clearly it is a thermal engine, not photovoltic. Catch the "turbines" line?
As to economical, time frame matters a lot. This is obviously a quite long term project. Unless something like fusion or "clean coal" works out it could be a quite good bet. And even then, it might be very cheap.
Re: PFE's Viagra
Wasn't it really an accident?
They were in trials for blood pressure and detected the happy guys!
Re: SPPI - bladerunnner
I think it's kool if the biomedreports/PDFUA chasers/HEB-CTIC crowd wants to chase this thing.
IMHO, the price ran up to around $5 or so on actual value. But the latest jump is probably the mo-mo lemming jumping on.
I guess I will have to sell around July 2.
The HEB show just keeps ticking on.
Nice PR. They take a PR from Biken saying they will expand their production capabilities for existing vaccine (that has no Ampligen in it).
Then they tack on their own paragraph that is designed to get the YahooHebHeads to think they will be using Ampligen for the Swine Flu run this summer.
AFAIK, Apmligen was only tried in a human flu trial as an adjunt once (a 2007 P2 trial in Australia). No results were disclosed, so it obviously failed. Not that I would bother searching hard for anything on this junk.
I would guess the timing of this PR virtually guarantees that the FDA CR letter will be disclosed about 8:00EST tonight.
Re: DORB, I think they plan to hibernate
The deal with Numoda put in place a structure that lets the P3 run w/o DORB. For a while they will try and pretend they are open for business (hey, maybe some stupid biodefense cash will fall in their laps).
But at some point they will put up the hurricane shutters and wait it out.
More from biomedreports on HEB
http://biomedreports.com/articles/most-popular/1168-biggest-winners-become-biggest-losers-after-fridays-action-on-the-street.html
>>>
Missed by most HEB investors were two positive developments.
First, Reuters reported that Japan plans to produce enough H1N1 flu vaccine to treat 20 million people by the end of year. The company has been in discussions and testing their flu platforms with that country for quite some time.
“The highest level of the Japanese government and public medical community is now focused exclusively on our product,” Carter told BioMedReports last week. “They stopped working on all other adjuvants (boosters) and are only working with this one because they’ve found that it enhances the vaccines by 100 fold.”
>>>
The HEB scam machine is convincing the sheep that Japan will be ordering millions of doses of Ampligen within weeks. I kid you not.
Re: Confusion and MNTA share price
I would see it as very unlikely that the generic Lovenox approval path confusion is having a significant effect on the PPS.
I would assume that any serious institutional money gets opinions from somebody who is well versed in this (and unrelated to the trash that gets published by the sell-side).
And I am dead certain that the average Joe investor has no clue what the discussion is even about. As a matter of fact, they would have no clue about any and all of 505B2, ANDA, biologic, low molecular weight herapins and small molecule drugs (except that the last one is semi descriptive).
If you don't believe me, just drop in a Y! MB for HEB
OT: also on 3 outs
By my count you could get up to 8 outs in a half inning if we are being loose on definitions.
Batter A) out[1] by any means
Batter B) K[2] dropped by catcher, advances to 1st
Runner B) steals second
Batter C) K[3] dropped by catcher, advances while B->3rd
Runner C) steals second
Batter D) K[4] dropped by catcher, advances to 1st, B/C hold
And now. the final batter hits a long flyout[5]. In the confusion with all the K's all 3 runners cross home. The fielding team goes to 1st for the the real third out[6]. But if the fielding team were to walk off then, 2 runs would count. So they throw to third an appeal that B left to early, he's out[7], Repeat for C, he's out[8].
Of course it's a lot easier in the biotech analogy world, How many outs has Ampligen had?
The only question I have on Bavi.
Does it work for swine flu?
[I will appolygize in advance for this stupid post. I am suffering from HEB/PPHM/CTIC/GNTA sensory overload]
Poll question suggestion
First over hyped small bio to drop 90% in PPS.
The obvious list:
HEB
CTIC
GNTA
My vote is for CTIC, even though they have the closest thing to a real drug. The PPS rise is so obviously bogus that the fall will be hard and fast.
Re: Adam F and nimo
Adam is very negative on CTIC, and justifiably so, but his arguments seemed off to me.
He slammed the OS in the trial, but at n=84 in an indication that isn't quickly terminal you will not see much.
On cardio toxicity, the drug looks to be a vast improvement on the drug it is trying to replace.
And his comment "As to efficiacy, I won't even go there" was certainly snide.
OTOH, the point that even if approved CTCI is a horrid investment is certainly correct.
Re: nimo and CTIC PR
"Fool me once, shame on you; fool me twice, shame on me???"
You wouldn't be referring to the (no so) STELLAR trial data, would you
On nimo results, I would point out:
. It's a single trial that was not run per design, and recruited across changes in SOC.
. Very little Rituxin related data
. No CPOP (replacing doxorubicn in CHOP) data. The trial in question was as a single agent vs single agent (which is why the enrollment never completed).
Given all this, they seam to need another trial before cash comes rolling in.
But of course all this pales in comparison to the cardio toxicity of CTIC's debt and management.
P.S. Oddly enough, once more it seams like Adam F is likely correct for the wrong reasons.
Re: "I don't see how they can treat it"
Given that one must continue take Ampligen bi-weekly forever, it seems quite likely that they are treating the symtoms and not the (mythical or not) underlying disease of CFS.
Let's put Ampligen up against Red Bull and see the comparison
I think today's jump in PPS was more likely the lemmings buying into the theory that the WHO (or Japan, or Martians) are planning to buy 100,000s of doses to stockpile against the swine flu.
You really need to visit a HEB message board someplace like Y! to get a feel for this crowd.
RE: PCYC rights - loan payback deal seams fair
It looks like Duggan floated PCYC a bridge loan to cover the time until they could sell some equity. Given that:
. The loan terms look clean
. The loan was callable upon an equity offering
. The company clearly needed to raise cash
It looks like the deal was quite above board.
I would agree with you if it had been the case that the loan had been from an earlier time and Duggan was attempting to bail out with an otherwise unneeded offering.
------ 10Q
On December 30, 2008, the company borrowed $5,000,000 and on March 31, 2009 borrowed $1,400,000 from Robert W. Duggan & Associates ("RWD"). Under the terms of the unsecured loans, the company is to pay RWD the principal sum of $6,400,000 on the earlier of (i) July 1, 2010 or (ii) upon the closing of an equity offering or rights offering by the company. The loan bears interest as follows: (i) 1.36% from December 30, 2008 until March 31, 2009, (ii) the rate of interest in effect for such day as publicly announced from time to time by Citibank N.A. as its "prime rate" from April 1, 2009 until December 31, 2009 and (iii) the prime rate plus 2% from January 1, 2010 until the expiration of the loan. Interest is to be paid annually.
The principal amount of the loans have been discounted to fair value for balance sheet presentation such that the stated interest rate together with the accretion of the discount will reflect an estimate of the market interest rate during the term of the loan. As described in Note 5, SFAS No. 157 establishes a three-tier fair value hierarchy which prioritizes the inputs used in measuring the fair value of assets and liabilities. Due to the lack of reliable and objective observable data available to estimate the fair value of the $5,000,000 loan, the value of the loan was determined using Level 3 inputs. These inputs included an estimate of the probable term of the loan. The loan matures at the earlier of an equity offering or a rights offering, meeting the criteria stated in the loan agreement, or eighteen months from its effective date. Due to already initiated corporate events and the current cash situation of the company, the probable term of the loan was estimated at 6.25 months.
With the term established, the company used various methods to estimate the fair market interest rate of the loan. The first and primary approach was a market risk approach, beginning with the risk-free rate on the effective date of the loan increased by the calculated estimates of the cost of each of the different premiums a lender would require for the various risks taken. These premiums included the non-marketability risk of the note, the risk of default, the cost of arrangement and the opportunity costs. Using this methodology, the company estimated the fair market interest rate to be 23%. The reasonableness of this rate was then further supported by comparison to the outcome of the Black Scholes pricing model calculated using the following assumptions:
* Strike price: $5,000,000
* Expected term: 6.25 months
* Risk free interest rate: 0.28%
* Six month volatility: 139%
The calculation was performed using actual volatility for both the six-month and three-month periods prior to the loan effective date. The company's fair market rate estimate was further supported by market data estimating the interest rate on high yield bonds that the company believes would be of comparable quality to the loan.
As the terms of the $1,400,000 loan are the same as the $5,000,000 loan with the same expiration date, the company applied the same methodology to determine the fair value of this loan. Due to the lack of reliable and objective observable data available to estimate the fair value of the $1,400,000 loan, the value of the loan was determined using Level 3 inputs. These inputs included first an estimate of the probable term of the loan. The loan matures at the earlier of an equity offering or a rights offering, meeting the criteria stated in the
CTIC, HEB, GNTA, BVTI
I think Dew was dead on wrt his prediction that VNDA would lead to a lot of idiots getting burned on bio-junk.
RE: TNF's K/M curves
Given the few spaced out censors on the SOC curve, is not the entire "late time effectiveness falloff" likely due to just 3 patients?
Re: CTIX Pix event count
I meant 41 on one arm and 44 on the other. This was out of 70 in each arm. So the P for OS could get larger (but obviously not stat sig).
The main point though is that this is too small a trial to reasonably detect OS in a setting where patients don't die that fast.
RE: CTCI and Pixi.
I think the p-value slam was a little unfair at just 41/44 events reported to date.
It does really look like the drug works, effective as anthracycline w/o the cardio toxic problem
I have not seen the LVEF data before, and it looks clean to me (but I know ziltch clincly).
Agree 100% with PGS, good drug/bad company.
Re: BiovaxID, ABPI and Accentia
I'm not clear what your point is, but there are huge problems with this crowd.
First, the PR is claiming the endpoint was in vaccinated patients, not the ITT group. This is more than just a statistical purity issue, there is a real problem. The trial was not able to make the vaccine for all patients (and not able to be on time). This could easily have biased the results.
In the ITT population the trial did not do to well. You might also note the original N.
Second, they claim stat sig at some point in time, while the trial has been unblinded for quite a while. Hell, why take 2 shots on goal when you can go on forever.
Third, the trial was stopped early for no clear reason. There was a member of the DSMB who was clearly a pal of Biovest (or if not, should have sued the company). The reason the trial was stopped was obviously cash.
Two next generation version of this drug have already failed trials.
Re: 30% linear = 50% volume?
I would naively think .7 linear reduction is a .34 volume approximation reduction.
50% volume should just take a 20% reduction in linear dimensions.
I would imagine we are within the margin of error here, but I would be interested in knowing if there is a bias that could be resolved via technology, which may or may not be being used.
Re: Botox quix
The black-box is also on the cosmetic version.
Re: RPRX Scamminess
Regardless of how it all plays out, Dew was just plain wrong on this one.
There is a clear line between hype and scam. The problem is that nobody outside of the "inner circle" knows the story.
Personally, I think his post was more part of a pissing match than a rational statement,
Re: OT HEB: "Those include all of the failed studies HEB has conducted on Ampligen in any indication. "
Hum, would that not make it about 0.03 trials per indication?
BTW, I mark this as OT because any comment on HEB etc. is really not germane to biotech VALUES.
Re: Enron had lots of employees
There was a funny story about Enron's trading desk biz that said the traders would move from floor to floor when bankers came through to make them look larger.
I do agree though that it is possible to be a virtual bio. w/o being a scam. DORB was/is not a scam (despite Kantz).
IMHO, the clue scamminess in this space is clarity on clinical trials. About a year ago INGN (who I had never heard of) came out with a decent sounding PR that was rightfully diss'd w/o comment by all. When I tried to find the story I spent hours searching before I even could find what (if any) were the P3 trials for their drug.
Question. HEB has stated in several PRs that their NDA is supported by several (4?) P3 studies. Can anybody find what the studies are? Short answer, don't waste time with crap, if they have real data it is shouted out.
BTW, Did Dew ever actually call RPRX a scam? I heard him make many negative comments, but in a couple posts he clearly said (paraphrasing) "close to a scam".
Re: SPPI valuation
It seams reasonable that SPPI can keep the doors open with what they have now [Fusilev and Zevalin]. I expect the Fusilev sales to grow with the CC indication label expansion, and this more than offset the potential "false blip" from the leucovorin shortage.
A $100m sales target seams quite reasonable for Fusilev (sales over $150m in EU), so this seams to already cover the present market cap.
Going forward:
. Zevalin growth.
I don't think anybody will value this as much because of it's long commercial failure to date. POTENTIALLY it has a lot of value, but the "prove it" crowd wins this one hands down.
. EOquin
I would say this is the meal ticket. Bladder cancer is a high prevalence, expensive (because you live a long time with it) indication. EOquin is a prodrug for the chemo mitomyacin-C, and has the nifty feature that it isn't systematically absorbed so has a good AE profile. Given the pharmacokinetics are known and the mitomyacin is well understood, this seams like a low risk (relative to the world of biotechs) candidate. Of course, it's still 3 years out.
. The rest
Same as any other bio, Oz, the taxane, and the rest of the pipeline is nice, but hard to assign any real value to.
[I know nothing about OXGN]
RE: DNDN/CGRB/OGXI valuation - Whoops!
I think you are a bit hard on OGXI for not being stat sig for OS in OGX-11. Comming close (p=.07) with just 50 events is fairly impressive to me. Also, there is no reason (AFAIK) for OXi4503 to be limited to PC as a target.
Cougar OTOH seams to be in valuation la-la land. It's another hormone agent for HDPC, in a space that is getting crowded and already includes at least one generic. The fact that their drug has shown evidence of efficacy after others have failed does not mean that much as this is often the case here.
Just added:
I guess J&J thinks otherwise!
Re: ARRY's financing deal
Don't need Thomas on this one, it's kind of simple.
ARRY issued about $3M (see note) worth of equity to have the option of borrowing the $40M if need be.
Given how bad it is if companies wait too long and need to refi on bad terms, I have no problem with this $3M spend.
Note: The repriced warrants are probably worth about $1, while the the $7s were around .50, JMHO.
Re: YMI, the flip side of their licencees.
The EU rights are with Oncoscience AG.
http://www.genengnews.com/news/bnitem.aspx?name=46611097
GEN News Highlights
Oncoscience has withdrawn its MAA for cancer drug candidate nimotuzumab because it would not be able to meet requirements for approval from the EMEA’s advisory committee in time. The Committee for Medicinal Products for Human Use (CHMP) expressed concerns regarding the quality and efficacy of nimotuzumab.
Oncoscience holds the European license for this compound from YM BioSciences’ subsidiary, CIMYM BioSciences. The MAA, submitted to the EMEA on October 4, 2007, was based on a small Phase II trial. On November 17, CIMYM BioSciences notified Oncoscience that it planned to submit issues for arbitration to the London Court of International Arbitration (LCIA) as the firm felt that Oncoscience was not taking the correct steps to gain approval in the EU.
“The questions from EMEA regarding the efficacy of nimotuzumab are based only on data submitted by Oncoscience AG from an unplanned, retrospective, subgroup analysis of a single arm, open label, monotherapy Phase II study of 47 patients with pediatric glioma,” states David Allan, Chairman and CEO of YM BioSciences.
Oncoscience has completed a Phase III trial, according to James Smith, YM BioSciences’ investor relations representative. He noted that more robust information is thus available but couldn’t comment on Oncosciences plans going forward. [Care to guess the results of that trial?]
Re: Nimotuzumab
It was billed as an EGFR targeting mab that didn't cause the rash problems.
From day one everybody was a bit skeptical as the rash seamed to be quite inherent in the class.
The first real P2 trial it had was a disaster. Not only did it not come close to the Erbitux results in a similar trial, it barely showed a trend at all.
I previously thought is was a somewhat less effective EGFR that might get some modest market share due to the AE profile, but these results looked really bad.
Also, the cast of outfits involved in development is somewhat unusual. Originating from Cuba, and licensed ex-N.America by YMI to just about every unknown biotech you have ever not heard of.
Re: SPPI/Zevalin "Another could be the use of maintanence R after 1st line."
Zev is generally used concurrently with Rituximab, so I would not see this as a barrier.