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.
MNTA- I think with NVS releasing news of starting to set the pricing on the generic. the PPS could get a push closer to $20 soon. Heavy volume last few days indicates possible institutional/funds buys as well.
If I remember correctly in previous CC calls, TEVA has categorically said that they are very pleased with how their ANDA application is moving along with FDA for their generic version of Lovenox. If one would take this on face value, multiple approvals are more likely. Also would explain why Oppenheimer reluctance to raise their MNTA target significantly higher.
Oppenheimer expects MNTA's drug to be soley approved but the target went up by just 2$ ? Doesn't make sense..
Any chance this 'fake' gold news will bust the Gold prices ? I won't be surprised if investors run for the exits if this sh** hits the fan.
We all know the game Wallstarb is playing..just had his cronies short APPA hoping to cover as well as pick cheap shares...all the more fire if he falls short (no pun intended) on his expectations.
I will double my position if that happens but very unlikely..
Volume again today has been heavy..expecting to break 1.50 short term.
With approval, we could be in 3.5 to 4 range come March
I doubt that..you are just playing the 'cause & effect' mind game...hoping the herd will sell in order to get back in.
I saw most of the trades at the ask price today & volume was once again decent...
3 months to ago into PDUFA with high probability it will be approved. WHy would anyone sell ?? No tax loss either..
APPA is inching its way up albeit slowly but surely..
APPA - interesting to see continued buys albeit the volume is yet to build up. Definite 2+ target by Jan end.
APPA - the interest seem to be spiking. 2+ possible by Jan end ?
I doubt FDA would approve MNTA alone or earlier than TEVA. However my bet (9500 shares) is on Dew being correct
I am surprised they predict both TEVA and MNTA getting the approvals at the same time. Does that make MNTA's unique technology platform any more validated ?
FWIW, I expect MNTA to re-base itself again around 9.50 area until next Q call. It's very unlikely we will get approval by end of this year when especially FDA has yet to fully disclose their report on heprain supply chain safety.
Agree..every b*s*t*r*d in the company loaded exactly on 5th October including their distant 'cousins'.
THIS IS CLEARLY INSIDER TRADING.
MNTA - No insiders have bought any sizable shares for quite some time. Not so much lack of confidence but it does say that they are not expecting any FDA approval anytime soon.
If valuation can go as high as 81+ on single approval, wonder why insiders are not loading up already.
MNTA - I am curious as to why no insider puchases so far given end of 2009 is approaching, if indeed approval is going to happen.
MNTA - PIPE more likely with help of Rodman now....
I agree..I am on the sidelines as well waiting to pick MNTA in 8's
About a year now...7k
I sold all my MNTA after I listened to the call.
FWIW, two major issues is NOT conducive for approval near term.
1. The potential possibility of 12 years exclusivity being passed does seem to impact MNTA ANDA application contrary to some posts I have seen here.
2. Continued risk of contamination in Chinese supply chain for Heprin seems to be a lingering road block.
Cannot believe most of the traders got it wrong on the shelf placed at 2.70. 2.70 is PER UNIT which is 1.25 shares (one common and warrant equivalent to 0.25 shares). So it is really 2.70 / 1.25 = 2.16.
MNTA - Looks like everyone (traders) are piling on to short to get to low 10's area now. OR it could be someone driving the pps cheaper to scoop before the 8/6 for a possible good news on FDA approval progress.
MNTA slide this morning...some not-so-good news leaked out ????
This is 7+ stock on short term...
I predict 4+ on Monday...
Likely PPS will drop to $5+ tomorrow due to this delay. I can't imagine FDA to turnaround quickly with their decision just because company provided the data readily. We just have to get back on the line which means some delay.
MNTA Goldman Sachs Presentation
Listened to the presentation audio again today and I was particularly struck by CEO Wheeler's comments regarding their plans on getting 'ready' for production lunch of generic Lovonex 2H of '09.
Sounds like they do seriously anticipate FDA approval before the year is over.
The institutions buying at increasing prices points to one thing...FDA approval is very likely.
Thanks..will be looking at SPPI more closely now
Could this be a cause of concern ?
Ibritumomab Tiuxetan ( Zevalin) Linked to Risk for Secondary MDS and/or AML
In January, the FDA approved safety labeling revisions for the radiopharmaceutical ibritumomab tiuxetan ( Zevalin injection; Idec Pharmaceuticals Corp) to warn of the potential risk for myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia (AML).
The warning was based on data showing that secondary MDS and/or AML were diagnosed in 19 (2.6%) of 846 patients enrolled in clinical studies and expanded-access programs.
The incidence rate among those enrolled in clinical studies was 5.2% (11/211) at a median follow-up of 6.5 years. The median time to development of MDS/AML in this population was 2.9 years, but cumulative data show a continued increase in risk (2.2% at 2 years, 5.9% at 5 years).
Of the patients registered in the expanded-access programs, 8 (1.5%) of 535 developed MDS/AML at a median of 1.5 years.
The FDA notes that multiple cytogenetic abnormalities were described, most commonly involving chromosomes 5 and/or 7. The risk for MDS/AML was not related to the number of prior treatments (0 or 1 vs 2 - 10).
Ibritumomab tiuxetan is indicated for the treatment of relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including rituximab-refractory follicular disease. The intravenously administered regimen consists of rituximab followed by indium-111 and yitrium-90 ibritumomab tiuxetan
Traded some of my IDIX short term shares to NVAX today...
Looks like NVAX has better potential going into 2nd half of 2009
Anyone tracking KERX ? Today's news seem to be positive for this company
Dew,
In fall of 2007, I believe FDA issued a non-approvable letter to MNTA based on their concern of not enough information provided with regard to immunogenicity.
Is it remotely possible that FDA is not fully onboard with Enoxaparin based on this concern and would still ask for verification of clinical safety ?
TIA
Understood.
My interest in NVAX is due to two-fold:
1. If NIH could get involved, they must be seeing some value in their platform
2. With NVAX already having produced VLP vaccine for H1N1 strain, getting it tested using an animal model is not far off (with or without NIH help). And if the trials prove positive , NVAX platform gets validated big time
Somehow I see NVAX prospects got just brighter, thanks to NIH
What's so crappy about NVAX ? If NIH is interested in their VLP technology, any investor should be, granted it's still speculative but if their platform is validated by NIH, it will be another VNDA...
We might have next VNDA on GNBT.
Would be interesting to find out what kind of market (sales) they have in India & Ecuador & whether any saftey issues have been reported...
The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world.
NVAX up huge on the news of co-study with NIH on their VLP technology...what's interesting is NVAX claims they have already produced a VLP vaccine against the swine flu strain.....
8:04AM Novavax and the NIH agree to evaluate a virus-like particle vaccine candidate against the novel influenza A (H1N1) virus (NVAX) : Co and the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Disease, National Institutes of Health have signed an agreement to cooperate in the evaluation of a virus-like particle (VLP) vaccine candidate against the novel influenza A (H1N1) virus. Novavax has produced influenza A (H1N1) VLP vaccine against the strain recommended by the Centers for Disease Control and Prevention.
The movement in both IDIX and MNTA have been largely due to huge following on iHub board based on DD's analysis.
So when DD posts some negative twist albeit with good premises based either on recent CC or other news, same people who bought earlier start to dump.. Too many folks are looking for a free ride at DD's expense, IMHO..
I expect DD to say that he added more or something to that effect and lo behold, the PPS will stabilze & start its slow upward trajectory...
I don't see any major player either in IDIX or MNTA so far...
In short both of these stocks are driven by iHub sentiments..good or bad...
Agree..MNTA is dropping with above or at avg volume...it will go back to 7+ within a week
Sounds like financing is around the corner...this only means MNTA doesn't expect FDA approval anytime soon.
Now with this kind of new uncertanity, IDIX may fall below 3.
Most of the recent bump in its PPS was possible due to reasonable expectation of making decent money and now it's all up in a toss between bullish or bearish..
I am all the more certain IDIX will raise another pipe.