Great meeting! All officers are upbeat with the general consensus - approval will happen. They expect this sometime before the end of this year or sooner.
Why has it taken so long?? The Generic FDA Office is a small one. Never has this section seen anything so complex. Plus the Heparin crisis caused them to be even more cautious. MNTA has not heard anything negative nor asked to do any clinical trials. They speak to the FDA often. Patience my friends.
I asked about their cancer drug to one of the founders. "Absolutely remarkable in destroying cancerous tumors". In addition, Craig Wheeler metioned that it is hallmarked for pancreatic cancer. Plus, might be used in other cancers such as colon that caused the passing of my wife.
Dew - brilliant questions asked. He will discuss the replies with the board.
Stay well all - we have a top winner here :-)
P.S. To Motion Man - I'm 3 feet tall with a toupe' LOL
The most consequential Q&A at MNTA’s annual meeting pertained to Teva’s low-volume formulation of Copaxone and, specifically, to my assertion in #msg-51018349 that a hypothetical withdrawal of regular Copaxone from the market would not preclude the sale of generic Copaxone by NVS/MNTA. Both Craig Wheeler and MNTA’s General Counsel, Bruce Leicher, concurred with the assertion in #msg-51018349.
Wheeler and Leicher acknowledged that sales of generic Copaxone would suffer to some degree if Teva were no longer promoting the regular formulation of branded Copaxone; however, I don’t think many reasonable people expect physicians to suddenly lose interest in regular Copaxone just because Teva launches the low-volume formulation. (Bio_pete takes exception to this—see #msg-51008534; my own view is in #msg-51008910.)
In an impromptu discussion following the annual meeting, MNTA’s CMO, Jim Roach, expressed serious doubt that the FDA will approve Teva’s low-volume formulation based on the data reported in #msg-50939364.
For those interested in reading the paper I went ahead and downloaded the program and didn't get any virus alerts. It appears they use some program that restricts saving the PDF and limits printing (I couldn't print to a capture printer either). I don't think there is any way to prevent someone from doing screen captures though.
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