Hardly. Look at the notes of the review committee. They are nearly verbatim of the criticisms of the EMA concerning Takeda's MAA for Omontys. Actual patient usage proved the FDA's lone dissenting critic to be correct. The reality was that the FDA held its nose and approved Omontys in order to have an alternative to Amgen ESAs. They only approved O because the FDA was willing to experiment O administration in a controlled clinical environment that dialysis centers offered in the hopes O would prove safe. O proved itself not safe and now the FDA has egg on its face. Go ahead AFFY longs buy some more Laffystock.
The entire ESA drugs kills people, because it is administered to frail people, who has multitude of complexities and they take numerous prescription drugs. Takeda will use the 25000 cases to arrive at a specific population for which the Drug could be administered.
They might get 60-70% of the population, where it is going to be much safer and avoid any allergic reactions.
It should hit the market soon watch for it. For 25000 patients only 116 had reactions, which is less than 1/2 % of the administered patients, who are chosen at random.
Now they have the statistics, sort out the patient population who will ever get to this reaction, this sample information will be of immense help!