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Dew, I have been lurking (obviously) and will probably sell also as the timeline seems pretty long for steady company income. Flo, many thanks for your optimistic friendship and research, please stay in touch. Mouton you have been so helpful to me in helping understand some of the patient issues, (that would be back when they seemed relevant and tilted toward Momenta), many thanks. MTB you know me from other forums and I am sure we will continue to correspond. jbog you have the last word (for now) but I can't wait for telomere lengthening therapy so, it looks like that will stand for the momenta (joke there). Dew, can't tell you how much I have valued your insights and have learned a great deal from you to the point where I was asked to co moderate the Imetelstat.eu board re Geron Co. Thank you for that. I know I will never be able to contribute anything comparable to what you have done here. (Perhaps you might take a peak over there and see if anything is of interest to you.) The last time you sold (but did not close out your position, years ago) at about 22 if I remember correctly (and you were clear to state so on this board when you did) was a good time to sell so I think I will follow suit also. Can you let me know where you plan to focus your attention next so I can continue to follow and we can continue to stay in touch? Best wishes, biopearl
That would be nice, flo but we are not that far along in the study process I think. bp
Thank you as always Dew and flo. But there still is the issue of at least two years (?) before revenues beyond development milestones, correct? Best regards, bp
It interesting that this string of legal losses and the threat of treble damages (the realization of which or not will probably be locked in the legal system for a long time anyway) has been baked into the current price. While the original hope of much more appreciation has been lost to date, something is helping to support the current price. Is it the hope for sale of assets or acquisition? It does appear that any major income events otherwise are deferred until the early 20's. Would appreciate your thoughts. bp
Flo, congrats from an old friend, bp
Mouton, it is often the pharmaceutical chain itself. For example, if you go to CVS you are likely to get one generic they have contracted with vs Walgreen's where you get another. I do think it is chain wide are at least regional. bp
GrthzGD, think lupus (SLE), scleroderma etc. bp
the bomb was already there when Pfizer took over and its name was Hospera (delayed fuse). bp
An unlikely ray of hope? This is from the Nov 27th letter: "We will continue to manufacture and deliver select presentations throughout the upgrade work taking place but do anticipate backorders and product shortages. " It is now a week later and much later than the Stefel conference. One would think Momenta had an obligation to inform earlier and if they didn't perhaps the notation about "select presentation" includes copax 40. I know that is a pretty optimistic view insight of just how poorly things have gone. I can imaging Pfizer isn't on the hood for some measure of compensation for failure to deliver. It will be interesting to see what kind of damage control Craig comes up with. I suspect it will be an acceleration of Ivg programs as mentioned by others on this board. Regards, bp
Flo, judging by your picture, one suspects you might have a vested interest the the hair growth prospect. Just an old friend, giving you "the business". bp
I imagine its pretty hard to keep secret when an FDA inspection team shows up at your facility. The recent rising price in the face so much bad news coupled with the canceled conference probably means something. bp
Am thinking shaman/sage burning or priest/exorcism at this point. Or just perhaps surgeon/portfolio excision. bp
Dew, thanks for responding. It would seem that over the short term there will be three Copax 40 mg products on the US market once MNTA is approved. The value to MNTA should still be substantial but not a windfall. After copax and beyond milestone payments, do you see that next value creating event as market approval for the Orencia copy? And, Illegitimi non carborundum etc from an old correspondent and friend. bp
jmkobers, thanks for your good wishes. Yes I do value Dew's opinion. This company has a the blackest of clouds. I don't blame anyone here (Wheeler is not in the building) for not foreseeing the McPherson debacle which is largely to blame for the recent decline, otherwise MNTA would probably still be ahead of the curve. I will continue to hold for the promise of bioequivalents that may lead the way to market, especially with partners like Mylan and CSL. I followed the legal cases closely with the help of some board members here and no one could have predicted the crazy turns that has taken. I think any investment with major appreciation potential will require risk and thinking differently than others. Ups and downs can be awful but up is better I expect setbacks and we are in one now. And yes I am waiting for the Dew view. Best wishes, bp
Dew, when you have a moment, can you weigh in as thought leader for this board regarding current status of the situation. It would seem that things are oversold and with the eventual and probable short term approval of MNTA copax 40 that it would be reasonable to expect some modest recovery. My question is whether one should reevaluate the idea that MNTA remains preeminent in making exact copies of biologics or has the basic premise for owning this company changed materially at least until we get to IVIG program. Thanks, bp
Fellow board members, 13 is getting close to my entry point of about 10 years ago and I continue to hold. Wonder if anyone thinks the basic premise of being able to make exact copies of biologics (MNTAs raison detre), that presumably would be attractive to the FDA has been challenged to the point of invalidity since clearly other competitors now presumably have workarounds that perhaps initially some including myself thought would be unique to MNTA. It appears to be a world driven by legal hurdles even more that biologic ones. Once MNTA Copax 40 is approved clearly some additional and substantial income should be derived and the decline should reverse. Not what we thought but still not hay. Is anyone of the mind to continue to hold? Clearly Mylan looks to MNTA for their future biosimilar program but this and the antibody program both of which may prove successful have a long timeline. Thanks bp
It is probably reasonable to expect approval of MNTA 40 mg in the near future but since anticipated model of only one generic, not two at least initially would be off the table, can we anticipate an "authorized generic" from TEVA at that point? Anyone able to offer a model of what that market would look like? This appears to have been a long run for a short slide. Future value creating events do not seem apparent over the short to immediate term. (2020?) Keep smiling. bp
DaveAu, its just the FDAs way of saying thank you to MNTA for solving the Chinese tainted heparin problem and saving many lives. No good deed goes unpunished. bp
Very odd that here we are on the cusp of 40 mg approval and the stock price is down. Given the scrutiny that Mc Pherson must be getting from all parties, the likelihood of approval should only be increasing. I wonder if the chatter is a just someone walking onto the the exchange floor in the middle of a drought in a drenched raincoat. bp
Flo, I hope you are right. I would have thought so too but for Wheelers comments that they had not yet gotten into their cars etc...
Does the FDA really have to get in their cars and drive to Kansas? Maybe we could chip in for airline tickets. If we see any well dressed hitch hikers carrying brief cases perhaps we should give them a lift. bp
Sure, your Lambo for my walking or should I say waiting shoes. bp
Flo, you (and Dew) have been great about posting interesting relevant information for us. Just wanted you to know how much it is appreciated. We have been at this one for a long time. Best Regards, bp
Wow, that was unexpected at least by me. So does Amphastar now get to keep the bond and bring forward its anti trust suit? bp
jbog, yes one of the Judges memoranda kindly referenced by mouton, referred to his requirement that each side limit testimony to 12 hours. No mention was made as I recall about a time allotment for cross examination so I don't know if he intended to include cross as "testimony" or not. bp
Dew is that because of the inevitable appeals and the as yet untried antitrust case? Is it possible that the outcome of this case will potentially lead to an alteration in Amphastar's antitrust case strategy the premise of which seems like a stretch? And jog thanks for the timeline update. I suppose some of the time this case is taking is related to administrative necessities like jury selection etc that precede actual trial material presentation. bp
If Day four was on the 13th, they must have each used up their allotted 12 hours by now!bp
mouton, looks like trench warfare, thanks for posting and please keep us posted. bp
Yes they did and they should pay triple damages for it. bp
Mouton, This must have been it. Thank you bp
jog, I based that statement on a recollection from many years ago regarding the original district court ruling in favor of Momenta regarding patent infringement. This ruling as I recall was related to patent infringement but I no longer have any references for you. I remember reading expert opinion and just am basing my statement on recall which could certainly be faulty. Before all the safe harbor litigation there was a district court ruling on a patent issue which if I am remembering correctly went in Momentas favor. Does anyone else remember this? bp
Indigo, I am not an attorney but from having followed this case closely with the help of mouton, Dew and flo, the safe harbor defense does not exist for Amphastar and has been settled by long tortuous litigation. Safe harbor protection does not extend to Amphastar. Also the issue of patent protection also seems to me to have been decided long ago by the district court in favor of Momenta re the '833 patent etc. Where Momenta has a potential problem is with Amphastar's equitable defense argument. Mouton has pointed this out and kindly provided a summary of the judges rejection of summary judgement motions in a drop box a couple of weeks ago, it should be easy to find in June messages from mouton, if you want to read about it. bp
Thanks mouton.
Mouton, the Ampha trial begins today. You have noted that each side is limited to 12 hours of testimony. Since this is a jury trial can a decision reasonably be expected at the conclusion of the trial or do you expect further delaying tactics. What kind of timeline is reasonable under theses circumstances. Thanks bp
The spirit of Dr. Judah Volkman is still among us! bp
Dew, what you didn't go? I thought you would be there is full F. Lee Baily form! ( or maybe Dersh?) bp
Mouton and Dew, just for fun and since we have followed the enox case for so long and because some resolution MAY be forthcoming how would you handicap the outcome? bp
Mouton, point taken. Thanks, It has been probably five years since we looked at the original DC ruling and subsequent Appeals Court rulings. You were very kind to correspond with me at that time. The case has certainly take some twists and turns. Nonetheless if I recall correctly, the original DC ruling WRT the validity of the '866 patent was in Momenta's favor with the subsequent derailment that followed being based on Amphastar's contention that they had Safe Harbor protection, which has now been established clearly that they do not (recall the "safe ocean" comment by a minority opinion judge). I also recall that Amphastar refused to turn over material requested one of the courts, a bold move indeed. As to the other contentions, the conflict of interest argument is very interesting but if the central issue is the validity of the patent, hasn't that been established with support of expert testimony and acceptance by the DC already, regardless of the other arguments made by Amphastar? It would seem that the court would consider this the central issue. There have been so many surprises that this has unfortunately reached the level of entertainment and a process that detracts from the layman's respect of an efficient legal system. Hope you are well, Regards, bp As an aside Flo, thanks for all the updates, and Dew, thanks for your gyroscopic leadership. bp
Mouton, thanks for the link, clearly not a slam dunk for Momenta, but doesn't the safe harbor still look violated by Ampha? Lots more murkiness here than I thought before. Will this trial be a jury trial and deal with potential damages? Or is it a judicial tribunal? Regards bp
Dew, was this a formal CRL or just an request for "more information" ? bp