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If this was true ( and we'll never know for sure) it just shows you how clueless everyone is about the dealings that happen in the backroom.
I got your point just fine.
MNTA post enox approval pricing had to do with TEVA not Amphastar. The market had 0 inkling of ampha getting approved. Hell, not even Watson knew they were going to get approved until they did. Then a preliminary injunction was issued, something that rarely gets overturned. Well, that got overturned. You can gloat all you want if that makes you happy.
My point is it was a curious/abnormal series of events that led us to where we are now and very easily could have gone the other way if the CAFC panel had one member over another was assigned. You can pretend like you had some foresight into it, or that the market did if it makes you feel good about yourself, but the fact remains you nor anyone could have predicted what ultimately occurred nor can anyone predict what will happen with m-copax if it is approved. But if it is approved, then there will be $ to be made.
. That's fair I guess, but deep down, those that have been here through the mEnox debacle know what I say has merit.
The is my feeling on the subject and I think want of the analysts upgraded MNTA because of a similar thinking
Or they can wait and hope the Court considers the issue in another case.
so if MNTA does refile, then it's safe to assume that their thinking is that the interlocutory nature was at least part of the reason.
Would MNTA have any insight into why the SCOTUS denied their case or are they as blind as us?
LOL!!! I was just joshin :)
Otherwise known as a buying opportunity :)
Gotcha. I didn't see the payment thing just the $28.8m loss.
Did they do that payment last year? Considering they'll probably only make $25-30m or so on enox, that $4m payment seems pretty high.
Looks like Rick Shea's guidance will be off by a fair amount this year...
I actually don't know much about Synthon. Thanks for bringing to my attention. I'll def do some research.
The only thing I would say is that the FDA accepted MNTA's application as an ANDA and has not made any indication that they don't intend to pursue it as an ANDA.
Is MYL actively working to get their application approved or are did they just pull a TEVA and did their drug on the FDA without tweaks?
Sole discretion of FDA.
Amphastar had some good lawyers and a fortuitous CAFC panel. That's really the only reason they're still selling their enox.
It will certainly be curious to see how much the FDA reveals of MNTAs ANDA if they do indeed approve M-Copax....I think it will be obvious from that as to whether someone will attempt to replicate it.
Do you expect the to receive approval at all? (I know the answer but you left the question wide open there :P)
jbog is it just me or have you been a little bullish on MNTA as of late?! :)
I assume MNTA/NVS will start stockpiling inventory now (like they did with enox)?
I also don't expect MYL to launch the same vitriolic PR war that TEVA did after enox was approved.
jbog, pardon if you have already opined on the subject, but do you think MYL has a fair shot of getting their copax approved at some point?
It's a game changer.
May 2014 versus sept 2015 is at least $300m to MNTA
TEVA won appeal on 2014 patents...don't see anything on 2015...yet
Revlimid as treatment for Hodkin's Lymphoma? Anyone have any insight in to this? I posted a while ago about my good friend's battle with Hodkin's and unfortunately she's relapsed.
She met with a lymphoma specialist recently and they suggested Revlimid which she has opted to do. Anyone familiar with it being used for that and success rate etc?
Also, if anyone cares to read her story feel free to check out here:
http://www.youcaring.com/medical-fundraiser/help-healey-get-healthy/70255
Congrats on ONXX Jbog!
I'm always happy jbog, always!
Seriously jbog come on. The info is straight from UBS as well as other analysts reading on the judges comments during the appeals and that's the "fact" I'm alluding too.
I'm simply opining my reasons for the latest price rise.
lol.
I think m-copax imminent approval along with the fact that the 2015 patent will most likely be overturned are what's driving the rise
CW lately has alluded to the fact that he expects HW to eventually be clarified correctly even if MNTA is not the case that does it. If it does take another case to clarify, would that ever have an effect on MNTA?
I wasn't as bullish as you on SCOTUS accepting the case simply because of CWs comments recently
I think that run up has more to do with the likelihood the courts will overturn TEVA's 2015 patents after the appeals hearing as well as m-copax getting approved in the near term.
Ah okay. apologies then for my false accusation : )
I think Jbog was being a jester.
So far stock price doesn't seemed phased by it.
Anyone attend the shareholders meeting? If so, anything of note?
Neither has anyone else yet, either.
If the case ends up going completely against MNTA, do you think we'll see more entrants if it becomes completely "legal" to use MNTAs patents?
There is no reason to suppose that MNTA management has any special insight into what the Supreme Court will do.
Yeah, recent comments from MNTA management have left me with low hopes SCOTUS will take up the case at this time.
Any idea why MYL even puts guidance out for it?
The only thing of note I see is Rick Shea's remarking on the speculation that the 2015 patents are vulnerable following the May 7th appeal hearing.
RPRX: The death of Proellex?
FDA Recommends Running Phase 2b Trial of Proellex(R)-V in the Treatment of Severe Menstrual Bleeding Associated With Uterine Fibroids
Press Release: Repros Therapeutics Inc. – 13 hours ago
Email
THE WOODLANDS, Texas, May 22, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.(R) (RPRX) today announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the treatment of uterine fibroids. The FDA recommended that a Phase 2b study should be conducted as a prelude to the Phase 3 program. During the meeting, Repros and the FDA agreed that:
The primary indication and label for Proellex-V should be treatment of severe menstrual bleeding associated with uterine fibroids. To this end, the Pictorial Blood Loss Assessment (PBAC) was identified as the key primary endpoint;
If the Company proposes a label that includes a claim based on patient reported outcome (PRO), such as bulk symptoms or quality of life, the PRO must be validated before the start of Phase 3; and
The FDA will review the protocol prior to study initiation.
Repros believes one of the key benefits of Proellex-V is the relief of the bulk symptoms associated with uterine fibroids and that inclusion of such claims in the label will provide a significant marketing advantage. The study will start in the latter half of this year and results are expected in mid 2014.
Additional discussions focused on the overall clinical and non-clinical program. The Company feels that many requirements have already been satisfied by completed studies using oral Proellex. The FDA acknowledged they would consider the information presented in white papers that Repros will prepare and cross-referenced submissions. The Company believes the completed studies with oral Proellex provide a very large margin of safety for the Proellex-V program.
Professor Alfred Poindexter, MD, Department of OB/GYN, Baylor College of Medicine, noted, "The early experience generated at my clinical site with vaginally administered telapristone suggests that Proellex-V may represent a useful, effective, safe and patient friendly option for the treatment of uterine fibroids in those women opting away from surgery in order to resolve their fibroid associated symptoms. The reduction of tumor size at the 12 mg dose was particularly impressive and will be an important consideration to both physicians and patients alike. Currently several of my subjects are in the third cycle of treatment using the 12 mg dose and are experiencing persistent benefit and have expressed a desire to continue treatment after the +1 year of exposure to telapristone which will be completed later this year."
The FDA also felt the pivotal studies should be one year in duration. The Company was already planning large one year safety studies as part of its overall clinical package. NDA submission is expected in 2016. The outcome of the meeting does not materially affect the cost of the total development program, but it does reduce the cash requirements for Repros through the first quarter of 2014.
Fat lady is warming up