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Re: MDCO before the US Congress
"Third, this bill would potentially benefit millions of seriously ill patients. "
The statement was made in the context of failure to protect late filers for the Hatch Waxley patent extension would cause bio's to reduce R&D.
Huh? Does he really think anyone would believe that companies will not develop drugs because of fear of counting to 60?
I'm not much in the "lawsuits for all" crowd, but this does seam fairly clear,
MDCO did get a bad break break though. If the FDA had been a few weeks late and approved after Dec 28 all would have been OK.
Re: Lawsuit on MDCO;s late patent extension filing.
"Wow. Not sure, but that sounds like a fine shareholder derivative suit."
Is that really true?
Who knows where the ball was dropped. For several years I had a job at a public tech company where one minor responsibility was patents. Every so often I would get letters from our attorneys that it was time to re-up, If I dropped the ball on one of these by mistake, I would think somebody might be real pissed. But it's hard to see a shareholder lawsuit,
If the pattent attorney's dropped the ball I could see a suit against them.
There is just ZERO chance that the company was not going to re-uo and changed there mind to late. You re-up even moderately bogus pattents.
SPPI: The flip side of Fri evening.
SPPI has a scheduled Q1 call Monday 1:00PM EST, but slipped the numbers out in a 10Q w/o a PR.
The strange thing is they seam quite good to me. They actually made a slight profit with 12M sales (9 Fusilev and 3 Zevilin).
With sound balance sheet, running break even, 2-3 likely label expansions coming, and a partnered drug in P3 things look bright.
But why hide it in a Fri evening 10Q?
Perhaps the run-up in PPS to $4 was more than just pre-FDA hype. Huh wallstrb?
Re: BMY HPRC data
Dew, you really are a little out of touch.
Per the IV crowd, Provenge cures HRPC, so there is little value in other drugs for this indication..
And if Vanna White sells them an 'Neu', breast cancer is also cured.
Even GNTA is flying, 50%
All the way back up to .008
I guess the momo lemmings don't care about a minor 6 billion share overhang at 1/5 of a cent.
SPPI: up 32%. Was it this news?
From an SEC 8-K
On May 6, 2009, Spectrum Pharmaceuticals, Inc. (the "Company") and certain persons (the "Investors") entered into individual Stock Purchase Agreements (the "Purchase Agreements"), pursuant to which the Company agreed to sell an aggregate of 432,200 shares of its common stock to the Investors at a purchase price of $2.70 per share, which was the closing price of the Company's common stock on May 6, 2009 (the "Offering"). The Sale resulted in gross proceeds to the Company of $1,166,940. The Investors included Rajesh Shrotriya, M.D., the Company's Chairman, President and Chief Executive Officer, and Shyam Kumaria, the Company's Vice President, Finance: Dr. Shrotriya purchased 290,000 shares of common stock and Mr. Kumaria purchased 85,000 shares of common stock. The Company decided to conduct the Offering to employees, including Dr. Shrotriya and Mr. Kumaria, to allow such employees to invest their personal cash directly into the Company at the current fair market value of the Company's stock.
The common stock will be issued pursuant to a prospectus supplement filed with the Securities and Exchange Commission on May 7, 2009, in connection with a takedown from our shelf registration statement on Form S-3 (File No. 333-150260), which became effective on May 5, 2008. The Purchase Agreements include provisions prohibiting the Investors from disposing of the shares of common stock purchased in the Offering for ninety days. The Offering was approved by the Placement Committee of the Board of Directors, which has the authority to issue securities of the Company from the shelf registration statement. In addition, the Audit Committee of the Board of Directors approved the Offering pursuant to the Company's Related Party Transaction Policies and Procedures.
A copy of the form of the Purchase Agreement is attached hereto as Exhibit 1.1 and is incorporated herein by reference.
Re: telaprevir quiz
An obvious guess would be that "undetectable" is (or might be) a little fuzzy in a single test at week 12, thus has been replaced with the 2log(10) cut.
Re: ZGEN's $300M
Looking a little closer, you have about half of that in non cash and rent obligations.
The liability on collaboration deals is not anything one would consider debt. They will not owe cash on it.
As far as rent, yes there is certainly a hit there, but far less than face value. They still need to rent office space over the next 7 years regardless.
As to the BMY cash, it is $95M for start of a P2. I really doubt BMY handed over the first pile of cash w/o plans to start the next round of trials.
"Sorry if you disagree. Good luck with it."
Thanks
Re: ZGEN's balance sheet
They have $152M in cash as of end of Q1, they have a $75M credit line, and they will quite likely receive a milestone from BMY ($80M? I forget). They also may well get a EU Reco milestone payment.
Please tell me how the balance sheet is that weak?
Yes, as with any bio if all the tech fails then so will the company. But the winter deadline seams a tad irrational.
Re: DNDN, bogus date, should be 11/7/2005
Looks like somebody got the PR from way back with a wrong date.
RE: ADLS and cethromycin
I would certainly wonder why Abbott outlicensed a drug that will compete against it's own Biaxin, and that was after running 6 P3 trials on cethro.
Even if it is approvable in CAP, what is the commercial story? It is going up against a generic w/o any obvious advantage and will carry a 18% net-sales royalty hit.
And there will certainly be more dillution (if they haven't already sold more this year, haven't bothered to go through all the SEC filings). The financials are bleak.
By all means if you feel there is positives that more than outweigh this, post the story.
Re: Pharmawire DNDN poll.
Where is the obvious choice?
D) All of the above.
The writers are stupid.
Their company is negligent for not catching the BS they write.
Whoever fed them this crap was spreading FUD.
BTW, the earlier piece picked up by FT was even worse.
Re: I think that ribavirin is almost as guilty
So why are these trials being designed to avoid the rash when rib is in both arms?
Re: DNDN valuation
Unless I am missunderstanding you, your ROW numbers are bogus.
DNDN could raise well over 300M for 7.5M shares w/o giving anything else away. Why on earth would they give discount stock out as part of a ROW deal?
Compare to ZGEN's IL deal and you would assume 300M w/o any stock would be in order for Provenge.
OTOH, the rest of the cash will be later than you estimate.
Regardless of this, the real kicker in Dew's starting point is how to evaluate potential HDPC use. I agree with Dew's way of thinking here, but it still leaves a lot of upside on the table.
Re: "Could Merck [Germany] be right"
That's the advantage of this play.
You have the upside of a small bio with the soundness of a big boy.
Of course not even Merck knows if the drug will hit. But they are not flogging a dead horse (which many small bios will do for lack of choice).
I was a little late getting back in, per the chart. Still think we have plenty of waiting time here.
RE: "Would it be correct to think that additional shorting would make it more difficult for the existing short to cover."
No, it's the opposite. If people are selling (new shorts) it's easier to buy (cover),
RE: DNDN - "under the best circumstances it will still be under review a year from now"
Uhm, perhaps a calandar can help you out?
Oct resubmission is very reasonable. That means an FDA date in less than a year.
I do agree the CMC section is far from clear.
Why would anybody want the DNDN trades X'd?
Seriously, If somebody was attempting to manipulate the price, then they just sold 3 million shares at about 1/2 fair value. They LOST about 30 million or so.
But I imagine you think that the trades should be canceled so they get off the hook?
I guess a few morons who had stop loss orders in got screwed, but at least they learned a lesson.
Re: DNDN SEC investigation
Why?
Re: freaking on news of halt.
No, the halt was 4 minutes after the stock started dropping fast.
I would guess a false rumor, followed by panic selling / stop loss.
Alas, not me.
But funny though.
BTW, seriously the swine flu issue is way overblown. Influenza always cause many deaths, and more so in less developed countries.
Re: Androxal and type II
There is plenty of speculation that Testosterone is useful for Type 2 DB, and it actually is used for such.
There is a fairly large trial due to complete soon on this exact issue, I guess that is just a RPRX scam also.
Or do you believe that Andro does not raise T levels?
OT: Wayne and other greats.
Could I nominate Pele?
WRT Tiger, it is true you can not compare scores and shots across eras, but you can compare relative dominance. Tiger is on his way to be one in that elite class of "could be the best ever".
Curling? Any activity that uses brooms is not a sport.
R: NVS quiz defitions
Would the US Gov and/or WHO buying vaccines be discounted for the same reason as the VA?
"Without Surfaxin and it's FDA approval it's "game over" here."
Never give up!
Did not Colorado once when 1/2 a NCAA football national championship on a 5th down play with time running out?
Here is the only data I have ever seen on Stimuvax P2 trial in NSCLC
http://biom.client.shareholder.com/releasedetail.cfm?ReleaseID=280221
In short, solid data in one pre-specified subgroup with unknown overall results.
I seriously doubt this is just data-mining based on the fact that Merck KGaA (the German company, not the US Merck) went ahead with a 1500 patient P3 based on it.
I left this stock several years ago based on expected timeframe, I believe the P3 is still enrolling.
I did notice that Merck KGaA took over the manufacturing also (obviously with an unknown royalty reduction). Probably to save costs for ONTY.
From memory there was nothing in the small molecule program that interested me, but they do have another immune drug still in pre clinical that might be worthy of attention.
DNDN, what is the HDPC/HIPC ratio?
I could easily see a decent percentage of of HDPC patients using Provenge (I absolutely would even w/o P11 data). Obviously the limiting factor is the ability to pay.
If they drop the price a little, you will increase this revenue but decrease the reimbursed revenue.
Tough call.
Would be a very interesting discussion on IV with all the high and mighty types
RE: DSCO and FDA capriciousness
WOW! Shareholders of DSCO may lose because the FDA just wont get along!
Question, how many times do you think the FDA explained their concerns to DSCO?
Despite PGS's statement the FDA is not an adversarial body. They quite definitely work with sponsors to help out.
Another question. How many impurities in the fatty component of sufficants are acceptable for newborns? [A question DSCO never tried to answer]. Is this a concern to you, or is it clearly outweighed by shareholder value?
Re: "Does SEPR claim to have figured out WYE’s strategy for lifecycle management of Effexor before WYE itself did, even though SEPR never made any attempt to develop or monetize this “invention”? I find this hard to believe."
But if this argument goes to court then both patents would be invalid and you would have no winners. If WYE can demonstrate they already knew said "invention" then SEPR's patent dies, While WYE's patent is already a zombie.
Of course it would seam this argument is obvious to TEVA and others, so my guess is the only winners will be the lawyers,
Re: It's a 10b5-1 sale (eom)
Yes.
But OT, it does show clearly a weakness in the 10b5-1 program. The plan did not designate the exact date, just a range. So, an insider COULD have made the trade a day earlier if they thought the data was bad.
The variation allowed within the planned sale program just does not work in the volatile biotech space.
I am certainly making no claim in this particular case, as I would have sold options on the open myself if I had this many.
As to the orriginal "nice compensation" post, it iis hard to know. He has been there for 13 years, so this could easily just be routine shares/options accumulated over that time.
Re: Forbes and DNDN
On the "how does it improve OS and not PFS" question, this was also Dr Scher's (?) position at the AC (and in his letter).
And I always considered it absurd.
The data said Provenge most likely does slow progression (just not stat sig on the metric used).
As a side point, with N = 500 we will likely hit SS in the PFS secondary.
Is that why the Forbes artical has added the "counting deaths" talking point?
Re: Adam F and DNDN NPV
Adam has generally presented a fairly balanced view on DNDN, and his estimate seamed reasonable and conservative.
The biggest plus side over his US numbers would seam to be pricing (Adam user 30K per), ADPC and "booster shots".
The biggest threats would a new "world order" on the entire medical system and competition. Is there a serious mid-term threat out there (CGRB's drug does not count)?
Further upside for Provenge sales is EU of course.
I think 30-35 would be a very reasonable number to see after an FDA go.
DNDN: strange PR, or am I just paranoid?
Have to go out for dinner/drinking in a few minutes so will miss the CC.
I assume somebody will post the obvious Q/A.
I guess the won't get much sleep then.
rkrw, the IMPACT results should be obvious.
Tommorows PR headline:
"IMPACT trial confirms earlier Provenge survival data"
Now, if you could tell me how many words into the PR the P value is mentioned, then I would know something
Brean has been bearish here for quite a while
And certainly it is a reasonable bet that Impact misses.
But his argument that Provenge has no effect and previous studies indicating (or trending) such are no more an artifact of crossover delaying tax. administration is somewhere between strained and complete crap.
The FDA certainly would have pointed this out in the AC briefing notes 2 years ago. They did not.
Whatever all the whackos think, the FDA stat guys certainly will do a better job than the anybody else (especially given that they have vastly more data).
Re; CGRB/DNDN
"The DNDN loonies are certain that the abiraterone program is a conspiracy to deny Provenge its rightful place in the prostate-cancer pecking order."
Given that abiraterone is hitting the hormone pathways for PC it would seam likely to have little to no effect on Provenge uptake (which hopefully would be used concurrently with hormone therapy after radiation/surgery).
I do think it has taken over from Provenge for it's place on the PC over-hyped list though
Re: DNDN fireworks per D Miller
My bet is he is seriously wrong regardless of direction (though I know he is long).
The trial will not hit stat sig.
With the ability to spin the PR data combined with the "near miss is good enough" effect the PR data will support a resubmission.
Net is that everybody buying overpriced options will eat them.
BTW, do people realize how large an increase of HR is in the 20 -> 22% number that DNDN states? It is well past what could happen due to any treatment effect and would need a ton of luck.
Re: "I think ZGEN management said the same thing"
I seriously doubt it.
RecoT's advantage is in safety, not cost.
ZGEN has had less than 1 year to spin up the market, and this while KG has been dropping the price on b-thrombin to milk market share. Was insulin replaced in 1 year?
Wrt DSCO, none of us really know what the CMC issues are/were, so it's kind of a crap-shoot on approval. The PR was really just fluff, but not BS
Wallstarb, 1-2 years?
How on hell could DNDN spin up a new trial and have a PDFUA date in 1-2 years?
"our fund", my ass.