and leave it to well capitalized Takeda to do the re-trials, which at this point are inevitable -- witness FDA's treatment of BIOD -- who's problematic trial was a lot more transparent in its diagnosis than AFFY's phase 3 issues (it's a given AFFY management does not acknowledge what they know) and bring Hematide over the finish line... $10 per share is reasonable given Takeda's current investment obligations to AFFY, the risk (delays) and costs (new trials) of bringing Hematide to market...this is a drug whose value will diminish the longer it's approval is delayed. Affymax management is in denial about it's inability to meet current challenges in an efficient manner as an independent entity. AFFY is a one trick pony with a broken leg...shoot it or sell it, Arlene.
I would like to compare AFFY's situation to what DVAX and FDA agreed on concerning HEPISLAV. FDA and DVAX agreed to only include people 40+ of age in their phase III trail lot- to lot due to AES in previouse phase III trails. And if approved it will only be for 40+. So I think AFFY has a good chance for applying only for CRF population.
The only relevant node of comparison is whether the FDA orders additional Phase 3 trials due to problematic first round Phase 3 outcomes. In the case of both BIOD and your selected comparator, DVAX, they did so. DVAX just did a very large (very dilutive) secondary to fund their new Phase 3 trial. BIOD will soon have to do the same, or secure a partner, or be bought out by a company that wants to take their pipeline forward... Given that the FDA in both these cases forced new trials upon the companies concerned, rather than allow any partial approval of the relevant drugs for at lease that segment of the treatment market in which the drugs have been shown safe and effective, neither BIOD nor DVAX offer any comfort for shareholders of AFFY.
If either BIOD or DVAX are considered to offer insight into the FDA attitude toward the situation of AFFY, then AFFY will be forced to re-run a Phase 3 trial, adding great expense, in terms of cost, delay to market and risk to continued partnership with Takeda.
The best option for current shareholders in terms of delivering value, is to find a buyer large enough to bring the drug through these challenges. Otherwise,if AFFY attempts to do it on their own, with what timeline and what success one cannot know, the result will be a huge dilution of the present value of the shares, on top of the 80% loss already enjoyed.
As Arlene is interested in maintainng her social and economic status as CEO of an Silicon Valley Biotech, her interests are not with increased shareholder value through the sale of the company, but rather with dilution of shareholder value, and the independent development of Hematide by AFFY, with herself in the continuing role of CEO. That's why we need her taken out to the back fence...will anyone on the BOD do it? Not likely, as many share her attitude. I see no solution here for current shareholders other than and "act of God," or some other hostile form of takeout.
Moreover, Arlene Morris, CEO of AFFY, apparently agrees with the current "Street" assessment of an appropriate market cap for AFFY, as she just did a completely unnecessary and ineffectual ( in terms of capital raising) Secondary of a million shares at $5 per share....the only impact this will have on AFFY is locking in the current market cap and price per share at $5 for the foreseeable future. ... This is why she need to be taken out the the back fence and never seen again (or redeem herself by selling AFFY, for whatever she can get, to a company--perhaps Takeda--big enough bring Hematide through the new obstacle course.)
playing devil's advocate, Hematide met all its primary endpoints to the predetermined standards agreed upon with the FDA when the trial was designed. All they have to prove is equivalent endpoints for efficacy and safety to the standard erythropoietin therapies in the combined pool of trials. The results had to fall within a hazard ratio of 1.3 using a 90% confidence interval. They accomplished that. As far as safety, Amgen's Aranesp already has a black-box warning for CSE’s; this is a known risk of this class of drugs due to the biology of erythropoietin.
The trouble with your suggestion is that it is the FDA, not yourself, that is the true "Devil's Advocate." The case of Biodel, which i mention in my post, is most instructive: Here BIOD, like AFFY, had a wrinkle in its Phase 3 data. The part of the trial that took place for its improved insulin drug, Linejet (and insulin is already widely used and established as safe) in India was effected by a mishandling and administration of over-heated insulin in the Type 2 Diabetes population--the Type 1 Diabetes population part of the trial--and the Type 2 part that took place in Germany and the USA--had no such wrinkle and met all endpoints.
The cause of the wrinkle was easily explained and follow-up safety test that were forwarded to the FDA prior to there decision bore out the cause as the mishandled drug supply.
Nevertheless the FDA demands full re-testing, not only of the Type 2 Diabetes trial for Linejet insulin, but also for the unaffected Type 1 Diabetes trial (which MET ALL Endpoints). The reasoning??? That the breakout of data from the trials to find the cause of the problem mishandled drug supply in the India portion of the trial was done "Post-hoc."
So the FDA is on a "perfection first" policy as a kind of ostentatious atonement for its well-documented past sins. Because they know a few Latin phrases in which to express this policy of atonement, they feel the need for logic of argument to back specific decisions is superfluous...too "modern" too "new-fangled scientific" ...They've got religion, and it's perfect trial results...
So does Hematide have perfect trial results?? Even if they had an obvious explanation as to why they don't (as Biodel had) it wouldn't help with this particular FDA.