In as much as the FDA (1) oversaw the Phase III trial results, the review of Phase I and II results, (2) review and oversight verified that there were no deaths in the trials, and consequently (3) approved the marketing of O, then would not the FDA be predisposed to believe their own certified original evidence and now be looking for a cause outside of O for the deaths/illnesses? This in addition to the fact that Fresenius seems to be an incubator for chaos (not following procedures) and death inducing germs (lack of cleanliness). After all, if the original O evidence has zero certified incidents and the clinic seems to have ongoing lawsuits alleging clinical malpractice and maleficence then what is the basis for affixing blame to AFFY?
Sentiment: Strong Buy
YES DEFINITELY but I think that it would be proper protocol that they make sure that they check everything out with the FDA regarding Investigation info and conclusions before they return Omontys. They do NOT need FDA approval since it was voluntary, however the FDA could easily turn around and say STOP, SHOW US PROOF if they didn't gain concurrence before re-release, which I am completely confident that they're doing or have already done.
Max you seems like a level headed guy, consider the stock trading at a 40M mkt cap. Do you really think this would be the case if there was hope? I would expect to see at least a couple hundred million mkt cap left iif this was stiil up in the air, no? It doesnt concern you that there is soo little faith out there on a relaunch of the drug?
The Investigation to clear Omontys is not being conducted by the FDA. Affy began the Investigation and then handed it over to their Partner Takeda who agreed to finance 100% of the total cost until conclusion. During the Omonty Trials any negative side effects focused on cardiovascular issues, allergic reactions incidents were mostly a "side note". If any Scientist involved in the Trials had a concern regarding a FDA rejection of Omontys, it would be due to CV Risks. However because some allergic reactions were signaled during Phase l-lll, Affy included very specific warnings and more importantly procedures to correct the adverse reactions. Personally I think Affymax and Takeda were relieved that the deaths were "allegedly" caused by allergic reactions rather than the more serious CV Risks identified during Trials. If the deaths had been due to CV issues then the FDA would have sent Affy back to the "Drawing Board"! NOW COMES FRESENIUS CENTERS, since the deaths are not CV related then we can turn to other causes, latex gloves, mixture of other drugs, cross contamination involving other chemicals (Acetonecomes to mind), bacteria, too much Omontys administered by minimum wage employees etc. Recent deaths at these Centers, 2 deaths in a few days, at the same Center sounds hauntingly familiar to what they "pinned" on Omontys!!!
AFFY and Takeda (not FDA) saw the few deaths and decided to pull the product while they investigated the cause. Takeda needs to satisfy itself that the situation is under control - probably by more stringent warnings and precautionary procedures - before relaunching the product. Once Takeda is satisfied itself, it will be easy for them to satisfy the FDA.
NOTE: Takeda recently had a similar situation with another anemia (not for people on dialysis) drug that had 1-2 deaths and took same action in Switzerland that they did with Omontys here. VERY CAUTIOUS company when it comes to situations like this...Much more cautious in their reactions than many American pharmas who would have kept product on the market during their investigation and simply issued interim warnings.