100's (HUNDREDS) of Rx's on the market with FATALITY WARNINGS AND MANY
with far worse mortality stats than Omontys. Just do a little google research or even easier, watch the evening news and see how many provide the mandatory caveat "and in some cases causes death"...
3 out of 25,000 (2 have already been ruled unrelated), while tragic, is NOT statistically significant in this industry. If every drug that had that mortality rate (or worse) was pulled from the market, there wouldn't be a whole lot left...
Maxdad is up to his old GS "steal from retail" Heinz trade tricks again. I will try to put his assurances that all is well into proper perspective. [ I am prepared for him to go ballistic again too.]
An AFFY investor ought not to just look at .02% O deaths and think everything is OK. A 02% O kill rate is too high: Dr. Daniel W. Coyne, a kidney specialist at Washington University in St. Louis, in a NY Times article recognized that “two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this” with Epogen/Aranesp. An AFFY investor also might ask what did the Fresenius letter fail to disclose? We just don't know. Nonetheless we can infer there must be other serious patient safety from what we do know. For example, RW Baird analyst Christopher Raymond's research, made after O was recalled, concluded "[L]ooking at FDA’s adverse event database for Epogen, Omontys appears to confer a 100-fold higher incidence of hypersensitivity and an 8.5-fold higher incidence of drug-related death (and that’s new). This analysis isn’t perfect, but we think the magnitude is such that there’s a clear signal here.” Also, at the time O was voluntarily recalled, Howard Sklamberg, J.D., director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, warned: "Due to the severity of the public health risk, [the FDA] want[s] to be certain that health care providers stop using Omontys."
I agree with your statement but somethings up and its not looking good for the company. I am neither long or short thought about buying this morning but didnt pull the trigger. After the FDA allows the drug to be on the market the company voluntarily pulls it. Then the Naz goes about delisting and the company doesnt even put up a fight, The wizard of oz is definitly pullinmg the strings behind the curtains. AFFY didnt have to pull the drug but they did, I bet the drug works great and you will see some big pharma company come in and buy affy for pennies on the dollar, I could be wrong but the recent situation tells me somethings up and its not going to benefit shareholders. I hope Im wrong for longs sake never really like shorting seems like anti-investing to me
i do not think there would be any drugs left on the market if that were the case.
This is really iffy now though.
Still, no one knows what is going to happen.
Who knows maybe Takeda wants AFFY to just go under.
Maybe Takeda will try and sell their license agreement to someone else.
No idea, lets hope for the buyout though
max: I agree, as I have mentioned before, Off-Label uses of FDA approved drugs should be far more concerning because they dont need FDA approval for its off-label use and therefore limited to no black labeling. I just wrote to Jagan, it just sounds to coincidental that the CEO went to Amgen, a company whose market share could be greatly effected by Affy's success. Amgen would double corner this particular market need, while getting a 2017 patent expiration, and they already have a relationship with Takeda, Frensius, and manufacturers and distributors. If so, how does Goldman Sachs negotiate this? Thanks