Thank you. A substantial part which is limited is the number I was looking to get. Must be top secret in affy HQ. I may add a position soon. After the statute of limitations has run out on filing lawsuits this may run.
The Company had federal NOLs totaling approximately $481 million at December 31, 2013, a substantial portion of which are limited due to a prior “ownership change” (as defined in Section 382 of the Internal Revenue Code). The Company’s use of the remaining NOLs could be substantially limited if the Company experiences another “ownership change”.
In general, an ownership change occurs if there is a cumulative change in a company’s ownership by “5-percent shareholders” (as defined in Section 382 of the Internal Revenue Code) that increases by more than 50 percentage points over the lowest percentage owned by such stockholders at any time during the prior three years on a rolling basis. The Company noted that the Rights Plan is designed to serve the interests of all stockholders by helping to protect the Company’s ability to use its NOLs to offset future tax liabilities and is similar to plans adopted by other companies with significant tax attributes.
Its a good find genedoctor. I believe affy managment will wait on any attempt to revive the drug for at least a few more months until no more lawsuits can be filed . Then maybe they may announce a partnership or reverse merger. It always appeared to me affys former partner T preferred to just write off the investment and leave the question about deaths unsolved. They were already knee deep in product liability and probably decided to just cut their losses. Im still trying to find out how much the NOLs are worth.
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.
gene were you able to find any reference to this article on the FDA website?
my gut feeling is those behind this will come forward with complete control of this drug and make $$$ leaving the old shareholders out in the cold.after a reverse stock split...
something went wrong??? what is the question....the positive far out weighed the risk...someone is behind shelving this product...maybe amgen and the old management??? by the way thks for your input
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.
This for the response...can the formulation be corrected...is this drug still in play? If so then this is or has been a huge scam on shareholders....your thoughts
Thanks gene, Affy supplied the API to the largest Japanese pharmaceutical company which was allowed to do the investigation into the adverse events by the Affy BOD.
It means that the formulation and not the drug was the problem
whc basically man what to affy sharehoes? r we F..Ked or what??? Keep it simpl for laymen. thks
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.
Do you have a list of these 72 investors? And how many shares in total do they own? We need to hold a special investor meeting to address several questions including that why the company does not show any activity and whether the product still has a chance to be revived. The company definitely needs new blood to get energized, meaning that the company needs a new leader(s)
I'm afraid I'm not in a position to speak to the future price of Affy. My concern is centered on the insider trading that occurred here including the BOD, management and Orbimed. The renewed relationship between former Affy execs, Fresenius and Orbimed in regards to Relypsa. Also whether or not adverse events were misrepresented to the FDA by Affy or Takeda. In that regard I'd like to know whether patients suffering anaphylaxis may have been coded as respiratory distress or some other symptom of anaphylaxis. Why would they allow Takeda to handle the investigation of the SAEs with its track record of falsifying.
Was anyone satisfied with the report from Takeda? Details please.
Where have the regulators been all this time? How easy is it for some charlatan lawyer to subvert state laws?
I bought into this company in part because the Fresenius letter of Feb.14 recommended physicians continue using Omontys as the results were similiar to those on Epogen. Initially the stock fell but recovered when analysts remarked about Fresenius' recommendation included in the letter. As far as we knew that was the last word from their largest most experienced customer. Nearly a year later a NEJM article sponsored by Fresenius revealed their Feb.22 decision to stop using Omontys the day before the recall! This is a very important fact that the lawyers claim to have no knowledge of yet they refused to expand the class to cover those who purchased after Feb.22. and I believe they delivered settlements that shield defendants from further prosecution for unknown claims for a $350,000 payoff. I have that in writing and would love to deliver it to a prosecutor if I could find one interested. I have tried contacting lawyers who handle legal malpractice and a law professor active in the California Bar who authored an article on waivers.