Calling Takeda or AFFY is a futile exercise at this juncture. Definitely they have allocated enough resources to do the research for a thorough investigation and re-launch of this product.
It is almost 8 months I would imagine, the investigation would have concluded and waiting for the PR at anytime.
Since this is Takeda, there won't be any leakage of any news to anyone and they will absolute secrecy and confidentiality of the outcome. As I mentioned many times, I'm here just because Omontys is under the able leadership of Takeda.
Having seen many of such adverse reactions in many of their drugs, it should be no surprise for anyone, that Takeda will provide a solution to overcome this problem by way of adequate prevention and additional black box warnings along with adequate training.
Stay focused and will leave it to the Takeda experts, for me this is once in a lifetime opportunity. I still feel there might be a buyout, if there is going to be further delays.
Otherwise expect the product relaunch and start receiving Royalty Payouts soon.
Takeda faced many obstacles in the past, remember this is a voluntary recall. FDA would have allowed the drug to continue, despite the reported deaths and Takeda wanted to be handled from its end, due to various issues dealing with AFFY. Takeda like any other Drug company, faced numerous lawsuits from other drugs for catastrophic events, even very recently they got out unscathed.
It is just a blip and I don't consider this being a major issue, though their silence is deafening and the delay is causing anxiety. In fact for shorties this should create more anxiety.
This is the just the first day reaction and well documented even during approval process and black box warnings, which can't be totally eliminated, rather could be circumvented by not allowing vulnerable patients not to opt for this drug, low dosage, sub-cutaneous administration with adequate precautions during first day administration.
Remember AMGN's drugs kill patients each and everyday, not just on the first day of administration,it can happen anytime during the administration.
Fact 1. No Takeda buyout of AFFY. This is just a pumper lullaby. Does not make any financial sense for Takeda to do that whatsoever for the reasons set forth in my earlier posts on the matter.
Fact 2. No royalty payments soon, if ever. Assuming Omontys ever does come back to market IN THE NEAR FUTURE, any royalty payments must be retained until AFFY's crushing litigation problems are resolved.