Re: OXGN results

"Median overall survival (OS) was 5.1 months for patients who received ZYBRESTAT and chemotherapy, and 4.1 months for patients who received chemotherapy alone. Hazard ratio (%95 CI): 0.71 (0.42, 1.22)."

http://finance.yahoo.com/news/ZYBRESTATTM-CA4P-Improves-pz-3970724632.html?x=0&.v=1

What exactly is these boys definition of "clearly demonstrated"?

Have no idea if the drug is any good or not, and maybe the results are good as a trend. But unless I am missing something the "hype detector" is blinking red.

Re: "Teva's only arguments are based on feelings of fairness in that they argue it is unfair to let Merck enforce the patent against them. "

Teva's arguments are that the patent was obtained improperly for 2 reasons and thus can not be enforced.

There is no issue of fairness at stake.

Either CRT did intentionally delay the patent, or not.

Either CRT did withhold material information or not.

It does not matter how unfair it would be to Merck. yes they will be the loser, but that is life.

Re: "When a trial is stopped early like this, because the drug displayed statistically significant efficacy (and safety), how then is the NDA handled exactly, since the trial was unblinded early?"

There was a predefined P value that had to be hit, and it obviously was. If there was a SPA then no argument. If not the as long as the analysis plan conformed to normal alpha spend (and the trial followed the plan) they are fine.

What they can not do is just peek at the data, say it is stat sig at < .05, and claim victory (a-la CTIC).

In short, they said going in they would spend some alpha (say .001) on the interrum. And when the trial hit that they were fine (there might be some grace margin between what the DSMB stops on and the defined trial alpha just to be safe).

Re: "BMY-ZGEN post-mortem:"

Since NVS sold their shares at 9.75 I think any further discussion of "fair value" is moot.

(Though I do agree agree that the BMS milestone payments were obviously at risk. To borrow Wallstarb's term, they were "bio-bucks".)

Re: MNTA Copaxone "This number will surely have to be raised if the ruling on the Markman hearing suggests that the Copaxone patents in question won’t stand up to legal scrutiny"

What's up with the delay? I would thing the parties need the Markman decision to prepare their arguments for a trial, so I do not understand why the judge would be this slow.

I assume the summary judgement movement from NVS would be based on inequitable conduct (as this would not depend on the markman decision, while non-infringement would). Is it possible the Judge is giving serious consideration to this?

Re: "What does FOB mean? Thank you. >eom<"

It normally means Freight on Board, which is a shipping term that defines who "owns" items in transit.

I think here it simply was Follow On Biologics

Re: Bernstein and MNTA

"Maybe he has achieved his goal, he could "change" his mind to."

And also in reply to some of DD's comments.

Remember the quote by somebody I do not know.

"Never attribute to malice would could be just plain stupidity"

Re: the MNTA decision

"The Court, therefore, finds it unlikely that Sanofi will succeed on the merits of its claims."

"Accordingly,the Court concludes that Sanofi is unlikely to demonstrate that the FDA exceeded its authority under the FDCA when it approved
Sandoz’s ANDA despite having required Sandoz to submit additional
information comparing the impurity profiles of its generic
enoxaparin with Lovenox."

"Therefore, given the deferential standard of review that this Court must accord the FDA’s scientific determinations, the Court finds it unlikely that Sanofi will succeed in its argument that the FDA’s approval of generic enoxaparin is inconsistent with its past precedent."

This lawsuit is ancient history.

Re: MNTA and the Judge, zipjet?

As long as the lawyers here are answering questions for free

Will the Judge just say yes/no on the PI motion? Or might he actually state/write his reasons?

jmkobers, Re: Dew's Army

There are many here who respect and appreciate DDs work for providing information that would otherwise be very difficult and/or time consuming to find.

But I suspect few here are just sheep who blindly say "If DD likes it, so do I".

As to the present market price of MNTA, you might ask DD what his sig line means.

Re: "The drug is FDA-approved for excessive daytime sleepiness and cataplexy. "

Jq1234 posted that GHB is a schedule 1 controlled substance, and then gave the definition. He is correct on this.

Xyrem is a schedule 3 controlled substance, because as you point out is does have a medical use.

It's the government, go figure.

Re: JAZZ options

If the stock does not reopen then the "automatic" excise function is based on the halted price. AH trading has no effect.

A holder can call up to a certain time (not very late for us retail toads, maybe 5 PM) to tell the broker to go the other way.

If somebody owned these options with most of the discount brokers and failed to act, they are screwed.

Saturday they will get a recorded message.

Re: GHB: "I guarantee you that a large percentage of them will be lined up at the nearest doctors office with symptoms of fibro. They know how to play the game. "

Might there be just a slight red flag raised when the Doc sees a 300Lb guy at 7%bf complaining that they are just too tired to get out of bed?

It will of course have to be their friends actually lining up

Re: "This entire thread is about our investment in MNTA, not Sandoz. Sandoz is a proxy for MNTA"

Wow! So if Germany was a proxy for the US during WWII I can understand why the French might be pissed

Back to reality. I think the suit is very unlikely to work, but does not seam frivolous. Damages are obvious, and the argument that the immunology tests were safety, not purity, seams to have some logic to it.

Even if the chance of winning is 1% it would be worth the effort.

Re: "SNY has not claimed that MNTA/Sandoz or the FDA showed sameness with SNY data, have they?"

Not to my knowledge, but the impression I got was many posters here thought that was what SNY was claiming. Particularly in that discussion about a week ago.

And I kind of assumed that was DFRAI's thoughts when he doubted that SNY knew that the FDA used SNY data to approve the Sandoz ANDA.

Re: "and how would sanofi be able to know that and let along prove it? you just throw mud and see if it sticks?"

If Lovenox did not exist, then clearly the generic could not have been approved (w/o trials).

It is the SNY confidential data provided to the FDA in the NDA that allowed the FDA to determine that Lovenox, and any generic, was safe and effective.

Even if MNTA/Sandoz could show "sameness" w/o the SNY data, this would get nowhere alone as the ANDA still needs to piggyback on the core SNY data

Re: SNY/FDA lawsuit, standing

My read was that SNY is claiming that the FDA improperly used SNY confidential material (namely the Lovenox NDA) and this caused the damage.

I would think SNY would clearly have standing on this argument, no?

Re: Shorting MNTA Oct 17.5 puts

I'm in this boat with you medchal (though I sold mine on the post approval dive to 18 after the pop).

That (along with my long position) fairly well has me tied up here. So I would like to see no serious good news until after Friday.

Hope the rest of you guys do not mind a few extra days waiting

Re: FDA's sovereign immunity argument.

I don't understand why the FDA can not make a stronger argument wrt the Was. Nat. Gas v DOE case, namely that sovereign immunity applied there also (Was it not argued by WNG? That would seam odd),

Really just idle curiosity, I assume that the PI request will be denied for multiple reasons.

Re: MNTAs cash flow based on reimbursement liability

The quote from Wheeler was that it would be paid off in 3 Qs if not earlier. I assume that this means before the end of Q1 '11, and maybe before the end of the year.

That would put end of Jan '11 as CW's best guess. That is just 6 months of sales.

Thus, I would go with $240M for the run rate for '11, subject to the rest of your argument that I agree with.

Re: MNTA, TEVAs ANDA status

"What I also find bullish here is that Teva is stating in January that their full immunogenicity testing results were submitted no later than January of 2010. And yet you still have Teva speculating that since they submitted their data a month after MNTA, that perhaps the delay of obtaining approval is that the FDA has had one last month to review this data.

Come on, it is August for crying out loud!. It has been at least 8 months, and 9 months for MNTA. That seems to be about as fecetious of reasoning as any I can think of. "

I disagree strongly with you. The argument that it could take the FDA the same 9 months for TEVA that they took for MNTA is certainly somewhat rational.

More importantly, this argument will play very well with the average investor, who has absolutely 0 clue what the FDA was discussing in the reply to the CP.

The good side to this is that it sets a window for when a "soon" decision would be. Once a few months have gone by, TEVA is obviously having issue(s) with the FDA, and that will be obvious to the more casual investors.

So a significant amount of market assigned risk will lift in the next few months. I would expect that around the time of the next Q CC we should see a return to a more reasonable valuation (presuming no bad news or course).

Re: restricted shares and tax issues

Just to expand somewhat on DDs answer.

Because the shares are granted, there is ordinary income at the time the are received. The IRS treats granted shares as if the company gave you cash and ypu then bought the shares.

For shares that may not vest, this occurs at the moment they are reasonably likely to vest (I forget the exact language).

Thus, the execs all had a tax liability, but could not sell the shares on the open market because they were restricted.

In the 2000/2001 tech crash quite a few got burned when they received stock at absurd values, were taxed at that, then the stock turned worthless. Yes, they could take the cap gains loss, but that can not offset ordinary income.

I was in this exact situation, but I was allowed to sell some of my stock when the company I worked for whent public. Else I would have been *&^%ed bad!

Re: "SGEN—Market doesn't seem impressed with the $900M figure."

Nor should it be.

There is no clue on how many candidates are covered. It might not be that impressive per target.

Also, with the exposure that ADCs have been getting recentlty, I suspect that many had hoped the royalty rates might go up a bit. Maybe that hope was unfounded, but the market is not always "efficient"

Re: MNTA quiz

The generic Copaxone submission (Dec 2007) was 3 years ago, not 2.

Re: MNTA quiz. "When the FDA gives the green light, generic versions of Copaxone will hit the US market."

This is not true as the FDA can approve in 2011 while the lawsuit is still ongoing. The drugs COULD (not will) hit the market then.

Re: "This makes no sense to me. If NVS saw risk adjusted value in IDX184 they would have partnered ..."

To be clear, expected value is NOT the "risk adjusted value". The concept of risk really precludes the ability to have a "risk adjusted" value.

Simple example. We have a game were some moron with plenty of cash is willing to bet even money that he can flip a can flip a coin heads twice in a row. The value of the bet is obviously for every $1 you bet you receive .50

So how does risk play? You have the advatage, clear. Should you bet everything? No (unless you are kind of strange). Obviously you should just bet some modest amount and play again. What should you bet? Depends on how much you have and your risk profile. But failing to double up does not preclude seeing a positive expectancy.

Back to the real world. It is VERY possible that NVS could see a positive expectancy in buying out IDIX or 185, but decided that they already had enough in the game.

Re: MNTA's confidential data.

An ANDA inherently relies on confidential data. If S-A had never provided confidential Lovenox data to the FDA, obviously the MNTA generic could not be approved.

But this is done in accordance with the statute, so it is legal.

S-A is arguing that by not acting in accordance with the statute the FDA misused the S-A confidential data.

This is not the basis of the reason the argument that the FDA could not approve, it is the basis for damage to S-A that gives them standing to sue.

Re: ' So, in theory, all companies sending in applications for approval "think" or "told investors that they think" they have met all FDA requirements '

This is a unique case, the FDA is approving a quasi-biologic (sorry DD) for the first time. And the response to the CP does outline a lot of the basis.

I doubt reality is as black/white as Rat's statement, based on the tendency of companies to be sloppy in public statements.

But I would bet hard that Rat is better qualified than anyone here to decide how precise the FDA recs are in this case.

So if Teva was delayed 1-2 months on submitting the imuno. data, I would put a small risk factor TEVA gets an approval next month or two.

Re: "o/t: That was the Cowboy's Clint Longley pass on Thanksgiving Day to defeat my Redskins."

Nope.

Just had to look up the year. It was 75. Staubach to Pearson.

Roger was always a very Christian dude, and it was him who said he just threw it up and said an hail Mary.

As it was to get to the Super Bowl, it was a quite big play at the time.

[Yeah, I am a Cowboy fan and admit that Drew did push off]

Re: o/t: ' I still remember where I was when "the pass" redefined "hail-Mary." '

Was not Cowboys Christmas eve win over (IIRC) the Vikings the play that redefined "hail-Mary"?

Boston does NOT define the world of sports

Re: << Sanofi asked the U.S. District Court for the District of Columbia for a temporary restraining order and a preliminary injunction that would require the FDA to withdraw its approval, arguing the decision was arbitrary and capricious. >>

The issue of "irreparable harm" is the same here as in an at risk launch. Since the courts have already decided that one, it seams like the temporary injunction would be denied within days.

Re: authorized generic

Would they really launch before they see pricing and the market share reaction?

Or is your definition of "immediate" a little broader than mine.

By the way. Thanks

Re: BNC.TO

“Twenty-five percent penetration of this market would represent $500 million in annual sales and an estimated $112.5 million in gross profit for Bioniche,” Mr. Martin says.

That looks to be the one time gross profit, not royalties as one might assume. Per this from the PR when the deal was struck:

According to the deal arrangement the Canadian company will receive up-front cash payment of $20 million with a potential for up to $110 million, based upon clinical, regulatory and commercial achievements of the drug Urocidin. "In addition, Bioniche will manufacture the product and receive a transfer price of supply."

Also, the P2 data needs a little explaining.

That compares with the company’s Phase 2 results, where patients achieved a 46.4% CR rate at 26 weeks in a population that was mainly relapsed but also included a few patients being treated for the first time.

That is on N=11. So what is "just a few"? Any hard numbers on this?

Re: DCTH, PHP vs TACE

In TACE the chemo agent is concentrated into the liver, but will flow systemicly with the existing blood flow.

In PHP the exiting blood is filtered. Thus you can get a higher ratio of liver to systemic dose.

The problem with DCTH is that the CEO is making such outlandish claims that nobody believes a word he says.

China is NOT going to pay $5BUS for some catherters, pumps and filters that can be bought for a million or so.

And we can only shake our heads about his repeated attempt to claim an OS benefit based on the crossover population.

Also, the patent for liver PHP is good until sometime in 2012.

May be a valid treatment option. Not a blockbuster.

Re: San Fran Whooping Cough

The vast majority do not understand the concept of herd protection and think that the idiots declining vaccinations are just affecting themselves.

Re: "Actually I have never been wrong"

LOL

Before 9902B came in you posted "does ANYBODY really believe the crap works" (paraphrasing from memory). Great call.

Your repeated claim that it extends OS a few months make clear you don't understand the basic math concepts of mean and median. A substantial number of patients will be alive at 2 years who would not otherwise have been.

Re: "The guided-missile scorecard to date is thus one withdrawn product, two commercial flops, and assorted rejects such as TELK’s Telcyta. All told, not a pretty picture."

I think T-DM1 should change that to some extent.

But for the early stage conjugates there will be many more flops.

Re: "Guided Missles" for cancer.

This term has often been used to specifically describe MAB/chemo conjugates.

I would consider the radio-MABs Zevalin(Yttrium) and Bexxar(Iodine) to also fit the description, but they came after Mylotarg.

And pre-clinical does not count in my book.

So for me Mylotarg was first, but not the only, "guided missle".

Re: Serial dilutars

Numerically, GETA wins hands down. They were so bad that posters on it's I-HUB board were trying to figure out the share count and were off by BILLIONS.

But I do think Jim Bianco should win on style points. In a CC he said "no dilution" when a PIPE was announced within a week.

He did screw up though this time. They are only asking for 400M shares. Even if the dialling for dollars finds the votes, I'm guessing they will be asking again at the ASM.

Re: selling volatility

This has done very well for me in the last year as a market strategy, Covered my trading losses and drug habit

Have been pulling back on this recently as the whakiness makes be a nervous nellie.