First of all it is only 3 Deaths reported from FDA itself, so much #$%$ from the Plantiffs!
All in all it is reduced to a simple D&O case, where John Orwin issues false and misleading statements. That is where the D&O insurance come into play. They will defend and it has nothing to do with the company's finances.
A clear mistatement of both facts and law. Jagan understands that AFFY is a losing trade. He is so desperate that he constantly disregards the truth so as to make it seem all is well when AFFY and O are total disasters.
"Affymax announced on Feb. 23 that the FDA was requiring a total recall of the drug as a result of a “serious and life-threatening” allergic reaction."
That doesn't look like a voluntary recall to me. No matter, doesn't change anything. And a recall, a class I recall, their most serious type, is apparently what the fda says it is at their site, normally not an order to remove the drug from the shelves. Still, it would be nice to get some clarification on who actually did order the removal of the drug from the shelves.
Whatsoever,Recall does not mean that drug is bad but Recall is use to re-install confidence in people for the company for two reasons 1.That company is not greedy to make money by putting health on risk so they are recalling product to inspect.2.That company is with public health where safety is priority.As soon those product come back to market,people have less fear and more confidence.
FDA has not authority to make a recall without court's decision. But FDA can always persuade the company to issue recall for safety concern. So in this case, FDA put some pressure on AFFY to make voluntary recall.
I had previously posted the transcript excerpts of John Orwin on the Feb 23rd Conference Call when the Raymond James asked him the same question. Mr. Orwin answered ambiguously that Takeda/AFFY pulled the drug in consultation with the FDA and did not want to speculate on what the FDA would have done had O not been pulled.