I didn't look for it there and likely not influential to FDA unless Affymax uses it as part of a case to revive the product. FDA needs a sponsor.
I don't think we can blame the old management or Takeda as they had as much to lose as anyone. However, the current owners of the product should be transparent with their plans. They would need to raise a great deal of capital to resurrect the product. Not sure they could raise much at such a tiny market cap.
They could simply sell the single dose vials and not market the multi dose vials again assuming FDA agrees. This is not a scam on shareholders but rather the risk one takes investing in the industry. Phenol is an accepted preservative and in this case something went wrong.
It means that the formulation and not the drug was the problem
Weaver et al published data in the journal Toxicology and Applied Pharmacology 287 (2015) 246-252 and concluded that phenol in the formulation likely caused the anaphylactic reactions and deaths. Authors are ex FDA employees. Phenol caused release of histamine from mast cells. Purified active drug did not produce the histamine release and the reaction was dose dependent and phenol associated.
In my opinion, this drug was rolled out too fast without proper training of the sites. in the quest for rapid adoption it was adminsitered incorrectly at the dialysis centers.
Affymax board announces decision to dissolve company
Affymax announced that its Board of Directors has approved the liquidation and dissolution of the company, subject to stockholder approval, and plans to distribute all available cash to its stockholders as soon as legally permitted and reasonably practicable after paying or making reasonable provision for all known and potential liabilities and other obligations of the company. Based on the information the company currently has available, which is subject to change, the company estimates that the aggregate amount of the distribution to stockholders could be a few cents per share, based on 37,490,095 shares of common stock outstanding as of April 30, and the remaining cash of approximately $4M as of May. The company's Board of Directors has approved a plan of liquidation and dissolution of the company, which is subject to stockholder approval. The company intends to call a meeting of its stockholders to seek approval of the dissolution and will file proxy materials with the SEC as soon as practicable.
So what. This is old data. the question is safety not efficacy.
O is not material to Takeda and furthermore they have no obligations to Affymax shareholders to disclose anything. I know everyone wishes it were not so however it is. Please realize that Takeda may never know what happened and be able to keep the drug away from "patients at risk". The number of events was so small that such conclusions are impossible. The only way to answer the question is with a large randomized trial.
Orwin sold his shares in a legal way under a 10B program so get off this. The SEC is well aware of his sale as he has filed.
Affymax will be delisted after Wednesday’s trading by Nasdaq as the biotech declines to appeal a ruling that because of the recall of its anemia drug, “the company no longer has an operating business” and is instead a “public shell.” That is an entity the exchange has previously said “could be detrimental to the
interests of the investing public.” Affymax has also announced paying $6 million to two suppliers of the drug’s ingredients. Shares dropped 24% premarket to $1.59.
but it is true. Read the contract. This is common language in deals between bio and pharma. Takeda doesn't have to buy the company to get the product.
The pumpers are at work.
Affymax has (1) renegotiated the deal with Takeda so at least the company gets something IF the drug is relaunched, (2) laid off most everyone and told the remaining staff when they are scheduled to leave (3) paid off debt and (4) hired a work out specialist to negotiate the AP, leases etc. This is a small unprofitable biotech does when you are going out of business or BK. They do not have the cash to defend the lawsuits nor complete the investigation let alone restart the company. There is nothing left for shareholders. Call me a basher if you must. Many years in business operations allows me to reach the correct conclusion here. I wish it were not so.