1.It will take that long to determine causes and to see if a new allergic reaction assay can be designed to check for reaction.
2. The government never does anything fast so assuming it is a " quick fix" it wont be that quick.
3. For all those claiming that a few deaths or reactions are nothing you are correct however when the alternate therapy ( epogen) causes no reaction deaths the fact that O causes deaths is a HUGE DEAL.
4.Thursday means nothing they are just having the REGULAR SCHEDULED EARNINGS CALL...they have not even had a chance to review all the data and autopsy reports to find a link.
1- wrong: The company and even the staff who administer the O injections already have a good idea what had caused those reactions. One thing is for sure: the first 25000 patients did fine and so those administrating the medication and who also know the medical background of those patients effected and know what other medication was injected at the same time. They also know what changes were made in February to those regimens. with all that information on hand it does not take a genius to figure out what was the culprit. I can almost guarantee you they already know the answers but need to document and show prof before going public.
2-Wrong: this investigation is not gone by government but by Affymax.
3-Wrong: there has not been any claims or prof that Omontys had caused those 3 deaths. As much as you like to lie about this lets stick with facts.
4-Wrong: Do you really think they can have a CC and nobody is going to want the answer to the main question on the table or do you think they can simply provide some financials and say bye? Thursday (or Wednesday AH, whichever is correct day) is not going to be big but it will be huge. They most likely can not divulge everything folks want to know yet but any positive hints, which I expect many such hints, will send the stock flying towards double digit.
Listen folks: Omontys is a wonderful drug that is used only once a month (hence saving the government millions and patient much discomfort) that is proven safe in over 25000 patients before something went wrong. Patients want this drug back as does government and dialysis centers. It will be back. Count on it.
Sentiment: Strong Buy
you are wrong on all your assumptions...1..if they knew the cause they would have disclosed it and fixed the problem without a need for a recall and as material evident it would violate sec laws to not do so.
2.The fda must green light the re-introduction of the drug you must live in a cave if you think that will happen quick.
3.if there was never any claim or proof that the drug didnt cause a reaction why did the pull the drug from the market?? why do you think the company is trading just above cash value if no problem with drug?(which as a doctor it was the drug as it happened within 30 minutes of administration)
4.yes they can and will have a conference call and offer no answers as they wont have any this early in the process. They already had a conference call 2 weeks ago and said bye....do you think you can assemble all data from 25k patients in 2 weeks and get an answer?
5. i cannot have a battle of wits with an un-armed opponent i am sorry you lost money here and it might be a good spec play if they can find the answers but it will take months
Also the FDA will probably take another look at O approval generally bearing in mind the disastrous results of the PEARL study. EMERALD study established O not inferior to Epogen and safe for dialysis CKD patients. PEARL study established O not inferior to Epogen and unsafe [O 130% more deadly than E] for CKD patients not on dialysis. The conflicting studies make no rational sense and even AFFY characterized the discrepancy in the safety profile as "inexplicable" and for which "there is no definitive answer."