I’d like to preface my comments by disclosing that I’m longer than a horse here. That said and all biases aside:
For those of you who assumed that the opportunity/binary play was related to Fresenius and “will they or won’t they,” and that the worst case was a $10 pps if the latter came to fruition, your head must be spinning today. The truth is that the announcement of 19 anaphylactic events and 3 related deaths was unrelated to Fresenius’ evaluation. It was a meteor, a bolt of lightening or choose your analogy.
Having said that, what happened? What we know:
1) Omontys has been administered to some 27,000 patients (clinical trials and on the market once approved).
2) Omontys was administered for more than 2.5 years (again, between clinical trials and once approved and sold).
3) During those 2.5+ years, there were no such reports of extreme allergic reactions.
4) Fresenius, in their internal memo last week, which was made public, stated that Omontys was “well tolerated” in a patient population of 18,000 and that allergic reactions were infrequent and that severe allergic reactions were almost non-existent.
5) Suddenly, in February and after 32 months of no such incidents, 3 deaths occurred which were attributable to Omontys.
So, the question becomes; what happened in February that caused these sudden adverse reactions, which were not consistent with the previous 32 months? Because the deaths occurred in a short span of time, this would certainly suggest that the deaths are likely attributable to so certain circumstances that came about recently.
1) Introduction of Omontys to new centers without proper training for the administrators.
2) Supply chain issues/delays, which may have compromised a few lots of product.
3) Contamination associated with certain lots of product.
4) In symbolic observance of black history month; excessive consumption of Hennessey among Affymax minority manufacturing personnel resulting in carelessness and subsequent contamination of product.
The FDA has launched an investigation, but the truth is that we may not learn the root cause. That said; consider the statistical probability of 3 deaths in 3 weeks when zero deaths had been observed in the previous 32 months. Coincidence?
And I'll add another circumstantial piece - the panic recall at 11:24 on Saturday night smacks of urgency and suspicion that something went wrong with recent manufacturing batches. They knew there would be more deaths if they didn't act swiftly, whereas if they were unsure of the cause, they wouldn't have killed their stock (and their reputation) so abruptly.
Another farfetched but real possibility are the very sick patients who had enough and commit suicide. Instead of inheritance, they leave their families with money-making liability law-suits. I had a (possibly similar) case in the O.R.
Sentiment: Strong Buy
machinious, lots of yapping from you and a long, drawn-out post. Nothing you say matters because the product is out of the market and will have the stench like phen-phen attached to it from now on. Stock is dead.
Mach......... I like you logic and agree. Reminds a lot of Elan's Tysabri drug that went through similar issues. Later it was found that it was the deaths were the result of drug combination if my memory serves me correctly.
AFFY is priced to go BK and Omontys never to see the light of day again.... I think it still has a lot of value once the investigate what way have let to the 3 deaths. JMHO
Thank you, reason why I bought today :), didn't make sense without full investigation and my senses tells me someone/thing other than drug caused the deaths, this will go back to $30 imho
Sentiment: Strong Buy
i parrot machinious sentement but the mere fact that OMONTY is being implicated as the cause of 5 deaths will keep AFFY from a recovery for some time. at least until the investigation results are made public. no one will want to buy shares in a company thats only drug may carry the risk of death. the day traders will keep this in a tight range. unfortunately i dont believe AFFY has found its bottom yet.