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:
> FISSION, POSITRON, NEUTRINO
Well at very least they get some naming points...
EXEL: Noninferiority and Equivalence for Survival Outcomes
Then they should have said NI, which is a defined bit of jargon even though it sounds like something it really is not.
But by using common English, they now are say something that is not NI. It is obviously not possible to show what they claim.
So why did they phrase it this way?
I know little of this company, but that type wordsmithing makes me suspect they have issues.
EXEL: Trial design question
Could somebody explain (or parse) this:
and the overall survival analysis demonstrates that there is no adverse impact on overall survival in the cabozantinib arm.
Do you guys think that Sandoz would accept the entry of another generic just so Momenta could receive some type of reimbursement from Amphastar.
I would like to see how Momenta would issue A/W rights to a patent that it already assigned exclusive rights to someone else. I'm sure Sandoz would have something to say about any settlement that would only benefit Momenta.
If I'm from the A/W side, at this point if they lost everything from here on out, I would think that my liability would be minimum if anything and I'd just have to design a roundabout to Momenta's patents. I'm sure I'd be exploring that answer today and I'd expect the FDA to welcome my response.
Quite so. The lawsuits against MNTA by the Attorneys General of various states that jbog hypothesizes will never see the light of day and won’t even be seriously considered. No further discussion is necessary.
To embellish this point a little, go back to zip's paper on duopoly pricing in an otherwise free market. The conclusion was that based on parties best interest without collusion the market would split at a modest discount to the monopoly pricing. With collusion it would split at full monopoly pricing (that part is obvious).
The market in actuality did split at a modest reduction from the prior monopoly pricing, so this is just free market pricing at work.
Neither a monopoly nor duopoly is illegal. It is illegal to collude in an oligarchy, but that did not happen based on the evidence. To say that prices would be lower with more competition has zero to do with the legality while in the duopoly market.
Even if that's true, and I don't know the answer for sure, does one have free reign to use a party's protected methods when such use results in material harm (launch of AG because of aL approval leading to MNTA reverting to hybrid mode) to the party that has the rights to those protected methods?
I would bet any amount of money that various courts would differ on this. So I really doubt we can come to a valid conclusion on this board on if the H-W exemption holds in this case (where the patent period exists past the marketing date).
MNTA:
And as we discussed in an earlier thread, SNY's launch of AG was solely in response to the FDA approval of Amphstar's product
Damages w/o a launch?
MNTA has already been damaged, are there any chances that Amphastar could already be on the hook?
MNTA would need to show that infringement has already occurred. That would take either the court to disallow the Waxman-Hatch exemption, or to consider the manufacturing already performed an infringement because the intent was commercial (particularly whatever was produced post approval). Is the second argument potentially valid?
Additionally, MNTA has to convince the Judge that the Sani launch was clearly a result of Amphastar's infringement. This one seams a fairly easy case to make.
Even a hint of this could seriously affect Amphastar's willingness to settle. Before I thought DD's terms were too steep. Now I think they are very doable. [Actually, I think the may be low, but MNTA should take something along those lines due to risk considerations].
MNTA: The SNY AG launch?
I have seen no sign of the drug yet. I would think this tends to indicate it is kind of a soft launch, and they are not going to push the present structure.
Putting aside each side's incentives in answering the question, my initial reaction as a nonlitigator was that one year is very long, but on further reflection, I'm not sure that is true for even moderately complicated commercial litigation. An elevator conversation with a litigator suggests that one year would be quick for most complex commercial litigation. Obviously the answer depends on how narrow the issues are, how many people need to be deposed, etc. In this case, even if you thought that the liability issue would not require extended discovery, I could imagine a great deal of discovery on various issues relating to damages.
Tinker, or any other of our lawyers.
My understanding is that one of the factors that goes into treble damages is the credibility of the defense presented by the defendant, and excessive delays could go into that.
If they only infringed in the submission process, they seem safe (as they are going by the letter of the law). But if they infringe in the mfg process and present a slow smoke and mirrors trial I would assume treble damages is a real risk.
You are asserting without explanation so let me at least be completely clear. You are saying that:
a) Momenta hoped to convince the judge of the impact to them by lowballing their potential damages.
b) Amphastar hoped to convince the judge of the impact to them by exagerating their potential damages.
I submit that that requires some explanation.
Re: Horizon script numbers
I can not vouch for this, but this Y!MB guy has posted IMS numbers at a tad over 600/week.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_D/threadview?m=tm&bn=5034&tid=74979&mid=74979&tof=12&frt=2
MM... First the PI, then one can ask possible scenarios... No disrespect intended... But it makes little sense to look too far ahead... Got to get on base before you can score a run.
How exactly does one market a drug that has been pulled off the market for lack of effectiveness?
What are your assumptions on pricing?
That’s absolutely false—NVS will certainly be harmed economically if Amphastar wins the patent suit. Despite the fact that NVS will keep a higher proportion of NVS-MNTA’s Lovenox profits following an Amphastar launch, NVS’ Lovenox profits following an Amphastar launch and a SNY authorized generic will be reduced to such a degree that NVS’ net take will be less than under the existing duopoly.
One more comment on Clark's puzzle.
I have not heard anybody discuss how the individual patient would compare to the ITT population of the wonder drug's P3 where it established 80% OS.
This goes to 2 issues, one is tags "real world" odds of being positive. Another is that negatives might well have some related condition that is affecting survival.
I kind of suspect though that entire point of this has nothing to do with the answer, but that fact that one has to keep digging past the surface. Both in Clarks's puzzle and real world biotech results.
As an example of the problem try finding any patent that held off competition through physical broadness of the patent for the entire duration of the patent.
Re: MNTA Settlemnets
When I tossed out $/s numbers, I meant total value of the company with whatever the deal is, not the settlement value.
Peter's and Dew's deals were very far apart. I thought your post was following on DD's. DD has 2 years delay, then 20(?)%. That is a good deal. Pete's was an immediate launch and 5(?)%.
I agree with you that if they get a PI, I would rather roll the dice than settle for Pete's deal.
On the other hand, DD's deal would be enough for me.
If MNTA lands the preliminary injunction, doesn't this increase the odds that they would ultimately win a permanent injunction? (I realize the odds may still be low, ...
I hope they will roll the dice and go for the permanent injunction as opposed to settling.
on exactly which "PI" you are referring to.
I think we are more likely to pool resources and get better quality transcripts. Their quality has gotten better though over time.
Roche might be able to replace Herceptin with T-DM1 in 1st, 2nd line BC in the next a few years. I doubt they'll be able to replace it in adjuvant setting any time soon.
Sorry, I was being semi joking in my reply.
What I mean is "no chance in hell". I would seriously doubt you were damaged at all. And I do not even know if the court would allow such a suit anyway. And I doubt you would get discovery, so you could never prove it.
Q: Can I sue this guy to recover any loss the same time he was trading?
Why? Am I the only person entitled to the truckload of wisdom that is waiting for us just posts away?
Re: Clark problem
Obviously your math is correct.
I thought that Clark was going for the false negatives when he first posted, but was surprised when he tossed out 30% rate, as 1/3 is the cut point at which the numbers flop.
So either:
Clark is using 30% to get the numbers close, and is saying there is still some minor unexplained effect we are both missing.
Or
Clark mistyped 30% and really meant 35% (which flips your math to B). In that case there still is another main point that I missed on the first cut that Clark still is looking for. If so I have a good answer (which would of course flip it back to A), but will keep my mouth shut.
REGN: Converts: The devil is in the details
Yes:
In connection with the offering of the notes, the Company plans to enter into privately negotiated convertible note hedge and warrant transactions with counterparties that may include the initial purchaser and/or its affiliates. The convertible note hedge transactions will cover, subject to customary anti-dilution adjustments, the number of shares of the Company's common stock that will initially underlie the notes, and are intended to reduce the dilutive impact of the conversion feature of the notes. The Company also expects to enter into privately negotiated warrant transactions with the hedge counterparties initially relating to the same number of shares of the Company's common stock, which may be settled in net shares or cash at the Company's option. The warrant transactions will have a dilutive effect to the extent that the market price per share of the Company's common stock exceeds the applicable strike price of the warrants on any expiration date of the warrants. The Company expects that the counterparties or their affiliates will purchase shares of the Company's common stock and/or enter into various over-the-counter derivative transactions with respect to the Company's common stock concurrently with, or shortly after, the pricing of the notes and may unwind or enter into various over-the-counter derivatives and/or purchase or sell the Company's common stock in secondary market transactions following the pricing of the notes. In addition, if the initial purchaser exercises its option to purchase additional notes, the Company may enter into additional convertible note hedge and warrant transactions.
MNTA:
5. Within the past week, I spoke with a representative of Innovatix about generic enoxaparin. The Innovatix representative informed me that Innovatix had been approached by Amphastar to discuss the possibility of Amphastar distributing generic enoxaparin through Innovatix to Innovatix’s members, which would include the members located in Massachusetts.
Didn't iwfal clarify in message 128548 that drug A cures 100% of the people who take it? Maybe he could restate the question, clarifying what the mortality and cure rates are.
DEPO: Are you referring to program-survival bias?
Of course. The trial may have just had bad luck, but is is certainly possible that PSB led them to overestimate the power.
DEPO:
What you said are NOT true at all! Look at BREEZE 1 & 2 result, the actual effect (actual change from baseline at week 12 for both Serada arm and placebo) were declining dramatically, NOT JUST RELATIVE effect between Serada and placebo.
DEPO:
The changes don't address one issue which seemed odd in original 2 trials: the drug did much better at week 4 than week 12 for both dosage groups - if it were really placebo effect, wouldn't placebo effect be more obvious at week 4 than week 12? I'd think if the drug is really effective, placebo effect should go down rather than up over time. Could the drug work only in short term (4 weeks), but effect wanes in longer term (12 weeks)?
Clark, had a good chuckle on your pun in the PM to me.
Yes I realize the P('pun word')<33% is the decision. And that is where I thought you were going.
My semi answer in the previous post was assuming P was unknown and one would make the logical (to me) choice of Y. In which case the action would be the same as many in the brain dead world.
Kipp, a nice day to you also.
I used the comparison to Provenge with respect to cost of manufacturing. This would have little if anything to do with the indication.
But of course, you responded with a personal attack for no reason.
I hear nothing but "show the facts" in response to any negative post, but in any attempt at real debate the supporters turn to insults.
If you have just been diagnosed with the disease which drug do you take? Why?
I don't want to waste time explaining ...