From AFFY 1Q 10-Q: AFFY predicted exactly what happened to Omontys
It is hard for me to believe that Affymax did not have some idea of the O severe allergic reactions prior to marketing. Look at this 100% accurate statement from its 1Q 2012 10Q filed May 9, 2012:
"The subsequent discovery of previously unknown problems with the product, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the product, and could include withdrawal of the product from the market. "
Maybe this is just a standard boilerplate warning, but it is eerily accurate nonetheless.
Childs play really!!! stuff24PAC .... do you even know my position on Affy litigation? Most likely $1m out of court settlement like all other Drug Co. do, Insurance should cover 90% of it. I am done wasting my time on you, read the entire 10k's or do not post to me anymore, stupid I can tolerate, Ignorance I CAN AND WILL NOT!!!
I have no idea whether AFFY execs suspected that Phase III deaths were due to sudden allergic reaction instead of 'Unexplained' as officially reported. I do not know of any evidence which says that is the case. If that were the case, just pure speculation on my part, .... if that were the case, then it seems like the best way to 'destroy the evidence' is to ship anything off to Japan and disappear forever. In corporate terms, this means going BK and delisting. In everyday criminal terms, this would mean burning down the building to destroy any evidence that might be uncovered during an investigation.
I agree its a possibility. However we have FDA involved here. Even though its a voluntary recall ( which is just a food/ drug industry lingo because FDA would have taken over the recall had they deemed it fit) affy/takeda would have to satisfy FDA for root cause. I am from food industry and I guess pharma has same standards if not stringent. Irrespective of whether they want to bring O back or not burning the house down might embroil them in worse state of affairs. Takeda cannot risk that. My understanding is( just speculation) that if Takeda has taken over they are confident about the overall trial process of the drug in terms of disclosures, risks and experiments done by affy in the decade before.
Anyways I am fully aware that even, if if all is well with O it still doss not guarantee that affy investors stand to gain anything.
Well this crushes your arguments in the past about the lawsuits. Potential investors are warned of a possible outcome which is not favourable and when this happened, affy disclosed it once they had all the documentation in place. I am not sure about the future of O or Affy- highly speculative, but in all probability mean lawyers stand no chance in their case.
DR you are mistaken. Look at how the statement was qualified: "previously unknown". All of the lawsuits allege that Affymax knew but failed to disclose. Also, with respect to TGC's observation, the same 10Q discloses that under the Takeda collaboration agreement, a worldwide database of Omontys safety issues is to be maintained by Takeda in Japan. As Alice remarked in Wonderland, "It gets curiouser and curiouser."