Not to forget, it is an “opinion” only, and no doubt, a blatant wrong one. This opinion is only based on the fact that it simply ignores proven medical facts, and, in addition, contesting the expertise of 30 European countries, that represent a leading position in medicine, such as e.g. UK, Sweden, Germany, France, Italy, Spain, Netherlands, Belgium, Austria, Ireland etc. etc.
Therefore that's certainly not not written in stone and I do not think the last word is spoken here. Beyond that: it smells. The Co should carefully look on “interferences” of interested AML competitors, such as e.g. Glaxo.
Nothing real happened here: FDA officers gave their “opinion” which ignores medical facts, that's all ! This has neither a significant influence on the availability of this treatment for AML patients, nor on the basic value of the product. However, FDA has to answer if their opinion is influenced by interested competitors.
The whole is a deja-vu of the first Ceplene request at EMEA. Also that time the market reacted with the same anger and distrust about this highly overpaid and incompetent EPCT mgmt. That's understanbdable, since this Talley is a proven champ in working with wrong timing and improper preparation, and this way killing existing market chances.
Therefore in sum, it are here not the technical assets or medical facts. Every serious and diligent management would not have produced that disaster.
We currently see shorting and bashing: But in fact this FDA matter has no effect outside the US. Not at all in all the important markets in Europe, Asia or in the rest of the world. These markets are altogether by far larger than the US market. That does not excuse this overpaid Talley and his gang : Instead of at first securing standing and progress in these other markets, they preferred testing the moody FDA waters, needlessly adding the loser history a further failure.
Talley is doing everything wrong, the track record of a dumb but most greedy loser. For killing the co he's rewarded with an outrageous income of around 800,000 $!They financed that by selling all the time shares below market price. I do not know any similar example of such fraudulent game.