I just registered today, so apologize if I am not following protocol. Have followed the MNTA board and Dew for years and have owned the stock for several years. I purchased more today. I am a practicing physician who prescribes Lovenox daily. I have several questions/observations and any insight would be appreciated.
1. Has MNTA/NVS actually been named as defendants in SNY's complaint? I know they list the FDA, Sebelius, etc., and wish to restrain the launch, yet I am uncertain if MNTA/NVS are actually named defendants. Clearly MNTA has a financial interest in the defense against SNY. If not named, can we file a "Friend of the Court" or similar brief? Can MNTA/NVS assist the FDA in its response?
2. My general view, right or wrong, is that FDA really does not care about the financial repercussion toward various companies, so how robust of a defense might they expect to launch? I am hopeful that they want to protect the intergrity of their process. Any thoughts?
3. If I am no mistakened, NVS sued the FDA a couple years ago relating to Omnitrope. How robust was the FDA's defense at that time?
4. I doubt very much that a federal court would consider an approval of a drug after 7 years of reviewing generic Lovenox ANDAs as arbitrary and capricious. Would anyone expect the FDA to point out any flaws in the submissions of TEVA and Amphastar to support the intergrity of the FDA's process? Might this spell the death knell for TEVA's application if the FDA has to defend the superiority of the MNTA/NVS submission over the other applicants to show that it has neither been arbitrary nor capricious?
Thanks for considering the above.