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jbog, if oral agents prove equivalent or superior your assumption may not hold up. Is there anything in the public domain to suggest superiority of copax over newer oral agents? Regards, bp
With such positive data from DEFINE and with the CONFIRM data looming (2nd half or 2011) as a comparator to copaxone, doesn't it seem that TEVA is just expecting a paradigm shift to oral meds to solve their copaxone problem? Even if FDA approval comes for Momenta's product can anyone get a handle as to the efficacy of the oral agents and the impact on the copaxone market? Dew, could you please comment and would you now in the face of these studies recommend a more defensive posture re MNTA? thanks bp
Floblu, keep posting, I like to know they are hiring and for what, there is useful info to be had there. Thanks, bp
MTB couldn't agree more. In my community 10 years ago there were about five AED's now there are literally hundreds. Those who are lucky enough to be saved by bystanders trained in CPR and AED use should probably be deemed as getting "sudden cardiac life!" Regards, bp
Just to clarify, cardiologists and cardiac electrophysiologists use the term "sudden death" to define a specific cardiac event namely ventricular fibrillation cardiac arrest. There are "sudden death" survivors who spontaneously revert back to a more stable rhythm (rare of course but it happens) or those who have "aborted sudden death" due to a defibrillator discharge or other intervention. I know it sounded like a "duh" but that's the lingo and there are recoveries from SCD. Regards, bp
Zip, why can't TEVA use a "forward engineered" process and do something similiar to what Sanofi does in terms of production. Momenta doesn't seem to have an issue with Sanofi's production process. If TEVA is doing something similiar that is forward engineered rather than reverse engineered, doesn't that get around the problem? Re analysis of the finished product and need for Momenta's IP to do that, Sanofi must have a way to check their own finished product or at various steps along the way, that doesn't seem to impinge on Momenta IP. Does Sanofi still have patents in place that protect against this type of forward production from a competitor? Thanks, bp
Can anyone shed light on what having a Foreign Agency take over VAC 2 might mean. He didn't say a foreign company but a foreign agency. Seems odd. bp
If the supreme court decides in favor of a case 5-4 decision its still law. I don't know about the FDA but its hard to believe their decision making process would require unanimity but some other reasonable process. bp
Thanks Dew, i thought the context was more patient comfort issue from less volume injection (hence life style) but I see what you mean, thanks bp
acgood, Interesting that almost a third of the presentation devoted to Lovonox/Copaxone issues. Clearly TEVA feels the heat. Regarding "life cycle issues" I think he meant "life style" issues--a bissle lost in translation there. Re FDA and lovonox, although it has been mentioned before on this board, CFO said current issues relate to evaluation regarding immunogenicity and are underway at a different part of the FDA from the generic approval part. If the current ASH presentations give us any insight, then as Dew and others have pointed out TEVA may not come up clean in this part of the product evaluation. Waiting with interest...bp
Zip and North, assuming TEVA doesn't cave and voluntarily withdraw their ANDA (not likely) what is a reasonable approximate time line for litigation like this to run to resolution? It would seem to the uneducated that we could be talking years here. Thanks bp
y3maxx and OC631, I don't think we WILL know by years end. TEVA said they would be "disappointed" if they did not get approval by then, and IMHO they (TEVA) will be disappointed indeed. I think MNTAs strategy is to "win by losing." That is, IMHO they intend to lose the patent case on its own merits which will force a TEVA admission that the drugs are not equivalent, this will bear out Dew's assertions if it happens. It seems a reasonable way to try to shorten the uncertainty since as Dew and others have pointed out the FDA does not "reject" ANDAs. This approach will eliminate the TEVA overhang and hasten the M118 timeline. bp
Zip and gym, thanks for your kind replies. Was it not said (FWIW) in recent MNTA conferences that they hoped for an M 118 partnership by the end of the year? That alone, accurate or not makes me think I should hold the options for a bit longer. But really, it looks like I need to break myself of this bad options habit. Regards, bp
Currently holding MNTA Jan calls at 17 any thoughts as to likelihood of any events (M118 Partnership) between now and then or should I try to sell. Thanks bp
At what point in this process does TEVA have to confirm or deny that its lovenox offering does or doesn't meet the FDAs five criterion as outlined at the time of MNTA/Sandoz approval? Can they just drag things out for as long as possible to keep MNTAs war chest as small as it can (eg market cap) or is there some process that eventually calls for them to lay down their cards? How might an "illuminating" question at tomorrows TEVA conference call be phrased (presumably by a perceptive analyst) to flesh this out? It appears they will continue to obfuscate until flushed. Can it be done? Regards, bp
Flo, unable to post PM, feel free to do what ever you wish with my post. I didn't post this on BV board out of respect for Dew's request that speculation re price, buy/sell strategy be limited to this board. If Dew approved, I'd be fine with asking the question there. Regards and best wishes for success, bp
Greetings to all and here's hoping for a very fine day tomorrow. My question is that if this quarters earning are in the .60 to .70 range and if a PE of 15 to 20 were applied to an annualized income (until costs to NVS are paid back) one can calculate a "number" for the short term value of the stock based on income (exclusive of copaxone etc.) My question is would that number apply if the "short" holdings were 0? And what does it mean that there are so many "shorts" (eight million) now. Is there a way to sort of quantify the additive effect in a rough approximation of what the effect on price is when a lot of shorts that are called to cover is? I realize its a rambling question but I am just trying to get at what it really means when there are shorts compared to an idealized situation where there aren't any. I ask because I have some Nov call options and want some guidance as to how to try to get at what a short term peak might look like. Thanks is advance. bp
Zip and Dew, does this translate for those of us who are nonverbal re accounting that the Q3 MNTA numbers will not show the anticipated bottom line profit but the Q4 numbers will? TIA bp
Vin, I agree, its not quite that they lied but I don't feel they represented the true state of the company (as I suspected but was too trusting to do much about it) to us and now its just going under. You and I had some unpleasant exchanges in the past, but in truth GTCB was thrown under the bus, regardless. An expensive lesson in several areas. Best wishes in your future endeavors. Regards, bp
Hello Vincent, See the tire tracks yet? bp
In the interim found the RELY study of dabigatran in acute coronary syndromes. Looks like an excess of MI in the treatment group, looks like we don't have to worry yet. Dag, however will replace coumdin in Afib for sure. bp
Message for Dew from bp. At the risk of getting referred back to the RMF section. I think we should revisit dabigotran. A colleague just returned for a conference and was extolling its virtues--1. Works in 1/2hour onset, easily taken orally (obviously not so easy in a critical patient). 2. No iNR or ACT or PTT needed to follow. 3. One size (dose) fits all 4. It is a direct thrombin inhibitor and is potent 5. Fewer life threatening bleed (CNS etc) than coumadin (not sure about Lovonox), Sounds like a competitor for the acute market as well for for thromboembolic prophyaxis in Afib patients. Not sure about the anti-inflammatory effect doubt it trumps lovonox there. I wouldn't mind waiting to discuss this later if the timing weren't so terrible with a fair potential for market release of dabigotran around the time of earnings release from MNTA. Maybe our threat is not TEVA? Thoughts? I know you have drawn careful and strong conclusions (RMF) but this drug sounds like a powerhouse and at the very least will make coumadin obsolete. Granted Coumadin and Lovonox are not used in the same manner now but that would change with fast onset and easy control and a direct target of thrombin whats not to like? Best Regards by the way, bp
urche, You are probably right about this in the sense it is easier for the physician, but the patient would (given the choice)I think prefer an oral agent such as low dose ASA (certainly of questionable value in DVT prophylaxis so not really part of this argument)or a few weeks of coumadin even with frequent blood tests, over a daily injection that leaves a lovely and perhaps painful abdominal ecchymosis and may not be easily (read comfortably) administered at home by patient or family. Not that its a bad idea. Are you aware (I am not) of any studies that promote continued low dose lovonox prophylaxis once this selected group of frail recovering patients becomes ambulatory? Your points about coumadin of course are well taken, its is hard to adjust especially in the frail and elderly and carries its own risks including drug drug interactions as you point out and there is no "low dose" eg INR<2.0 option of therapeutic value, unlike low dose lovonox. bp
Urche, don't you think those patients discharged from and acute care setting would more likely be maintained on "lowish" dose coumadin e.g. INRs of 2-2.5 for a month or two during the time of high risk? Coumadin is a pain but self injection on a daily basis is worse and to my knowlege provides no better protection. Regards, bp
Go seek thanks for your note, don't have the ability to PM but if MNTA keeps going up will finally have the resources to re up! Regards, bp
Might be worth keeping an eye out for GERNs imetelstat, which target the MM stem cell and looks promising, just entering phase II studies. On another note, Dew kudos, and warm thanks for bringing MNTA into my life. I have lots of long term capital losses from gtcb to offset my gains but plan to hold both, I know I would never have seen daylight again without the MNTA guidance you provided and am now close to break even with lots of potential left for MNTA. For any old timers, the gtcb conference call is tomorrow under new management. Looks like the goats lost rounds one through 10 on the biogeneric vs biosimilar discussion. Regards, bp
Blade, Thanks for the info. bp
Dew, found multiple sustained release OTC melatonin preparations just with Google search. Any ideas how these might differ from the Israeli product? Regards, bp
Dew, I have to go back and look!
While perusing the vitamin shelf at the local pharmacy I noticed a form of melatonin that was time release OTC 10 mg I think, do you think this is similar to the Neurim product? bp
Doesn't the emergence of an oral MS agent also make a favorable Markman ruling for MNTAs generic copaxone less important?
Well, there's always factor VIIa...not to mention Atryn.
It was a very unfortunate journey for gtcb under its previous leadership. Among other disappointments, the guidance they provided for 2010 seems a bit inaccurate e.g. human studies for factor VIIa to be presented to FDA (they have two more weeks, resolution of dispute with LEO in first half of the year, they have two more weeks.) Maybe the new management can restore some accuracy and trust for the few minority shareholders that remain. Any thoughts about the CD 20 patents in Europe and how the goats might be affected? Also, it would seem the company, at least what's left of it could be acquired at any time by LFB, yet they have allowed some "independence" (of course they are totally dependent on LFB) but leave it as is for now, is it so the losses don't accrue to LBF directly or is it to encourage continued entrepreneurship against continuing high odds? Regards, bp
Dew (or anyone else knowledgeable), given the current healthcare legislation that is now law, is there clarity regarding biosimilar, biobetter generic drug production? If not, could the FDA delay re MNTA be related to some need for legislative guidance for the agency? Thanks bp
To my knowledge it is May 20th. Not sure if this is just the titles or includes the body of the abstracts and if it includes "late breaking" abstracts submitted. Regards, bp
Postman, thank you for delivering good news about gerntalk. bp
That's breast. "Hope springs eternal within the human breast."
Nonetheless, the rats walked. bp
Micro, indulgent as usual. With the usual good counterpoints. Nonetheless, "biologic activity" can and must equate to clinical efficacy before one gets to go from the lab to the patient to prove whether it works. I mean you have to prove it works in the lab before anyone will let you prove it works (or not) in patients. The toxicity has been thrombocytopenia if I remember correctly, or maybe an anticoagulant effect. So what chemo agent out there is completely non toxic? The idea is to kill the bad cells then stop before all the good ones go too and if not transplant some bone marrow to make up for it. The abstracts at AACR show promise and yes it has been a long time coming. We don't yet know if any "late breaking" data will be presented. Okarma said he plans an 80 (OK, then he 50) center study for breast cancer. Surely that is not based on a drug that does not work. Besides, the real news is on the embryonic stem cell side. You've seen the video from Kierstad:the rats walked--THEY WALKED after stem cell treatment for their spinal contusions. I couldn't sleep for days (no kidding) after I saw that video. It was too exciting. Cardiomyopathy repair, cartilage, islet cells, the list goes on. This company is not your ISRG which could move much faster but still had its origin buried in the space program of distant past. Okarma says these are disruptive technologies, so far besides his warped sense of time and tendency toward hyperbole I have given the benefit of the doubt. We shall see. Lots of first class medical centers looking hard at a drug you say doesn't work. As for the money, yes, I've lost plenty, but I am still swinging for the fence. Best regards, bp
Hello Micro, Imetelstat has not be promulgated as a cancer cure particularly as a single agent, just the only agent in clinical trials that specifically targets the cancer stem cell. Many chemo agents are used in combination, the theory being that specific cancer stem cells remain active after chemo "debulking" and may specifically be responsible for recurrence. But you know all this and still have nothing good to say about something that finally distinguishes cancer cells from normal (the high levels of telomerase required for cellular immortality) Check out the current abstracts at AACR suggesting significant activity across broad cancer types. The Nobel prize awarded to Dr. Blackwell et al acknowledged the importance of telomerase. There is evidence in breast, glioma, NSC lung CLL, myeloma and more. Also a vaccine to target telomerase is showing promise in AML. I am content to sit back, be patient, watch the scientists do their work and be amazed. Good to see you back! Took you long enough. Regards, bp