Many of us stated we would hold until THE final verdict of this company and its assets. As gut wrenching as this may be, you haven't actually lost it until you have sold. Here are some very import excerpts from the most recent 10Q: *Yes there are risks and other risks stated in the financial statements, these are just very interesting things to note*
"The launch allowance will remain as a liability until we can determine, if at all, the timing of when that liability will be extinguished or if the collaboration is terminated. If our collaboration with Takeda is terminated prior to Takeda's recoupment of the balance, there is no obligation that we repay these amounts."
"Takeda has full decision-making authority as to whether OMONTYS may be reintroduced if Takeda completes the investigation and addresses the safety concerns to the satisfaction of the FDA."
"Moreover, Takeda has the right to terminate our collaboration upon an uncured material breach by us or even in the absence of a material breach with three months notice prior to reintroduction of OMONTYS, which termination would have a further material adverse effect on OMONTYS and our business and operations, as we would be highly unlikely to be able to assume the regulatory responsibilities required to maintain the NDA."
From The Pharma Letter article: "A total of 98 adverse events tied to the drug were reported to the US Food and Drug Administration, including 12 deaths, by February 22, 2013, the day before the recall." Even accounting for this 1 - (98/25000) = A drug w/ .99608 efficacy for safety and a possible $700 mil per year.
Good luck to all of us who hold until THE final outcome!
It appears that takeda just gave 3-month notice to Affy ending collaboration. Still unsure If all rights to Drug
now rest entirely with Affy. If so, this could be of significant value to other potential bidders. Any comments whether
this is incorrect?
My interpretation of it is that Affymax will get all the rights back to the drug. Also, Affymax did not "exercise its rights" pertaining to the NDA because it may be too costly or unable to meet requirements, but a new buyer can? This three month mention is REALLY REALLY important IMO as it could be a precursor to reintroduction given the three month timeframe for the end of collaboration.
So, are you thinking there's a possibility of a buyout? I could only see this happening IF the FDA were to agree to some expedited study/trial to evaluate single vial dose, using subcutaneous administration. JMO
I find it highly suspicious and irrational to simply give up a drug that is marketable, reduces treatments, and has higher safety ratios compared to some OTC medicines. This has been nothing but smoke and mirrors since the recall. Not knowing all the legal procedures/rules is what puts us at a disadvantage of knowing if we will benefit. Hopefully, which I believe there is, Affymax has plans for success and it includes the shareholders.