If we and Takeda are unable to rapidly identify and rectify the causes of the safety concerns to the satisfaction of the FDA, which is highly uncertain, OMONTYS may be permanently withdrawn from the market. The recall of OMONTYS has severely harmed our business, financial condition and prospects as a going concern. The recall has also limited our access to funds and the resources that may be required in order to address the safety concerns. As a result, we may be unable to continue our operations. In order to reintroduce OMONTYS, we would have to complete our ongoing thorough investigation, identify the causes of the safety concerns and provide a suitable plan to the FDA for approval. Accordingly, there can be no assurance that we can address the safety concerns and meet the requirements of the FDA for reintroduction. Moreover, even if OMONTYS could be reintroduced, the commercial prospects for this product may be permanently diminished and the product may no longer be commercially viable.
After investing $600 MLN of its own money + 400 MLN of AFFY's own money and almost 15 years of work you have a product called OMANTY's.
The ESA's are deadly and AMGN's drugs kills more people. The FDA approved the drug knowing well the risks. Takeda won't be lining up in the BK court fighting with everyone for acquiring AFFY. Rather they will takeover and deal with it in their own way!
Doesn't look like Takeda will be lining up for that fire sale after
all. They have aquired all the rights to the drug for a promise of some payments if the drug ever enters the market again. All Takeda has to do now is wait until AFFY goes BK and liquidates or until it closes the doors. Then Takeda won't have to pay, if the drug ever enters the market again, and that's a big if.