.If Takada had introduced Omonty"s under a 'Administer as Sub-cutaneous only' label, they could have had eight months of revenue from that until the investigation is complete. Maybe they didn't think the investigation would take this long? JMHO
I agree with you. There was no need for Takeda to withdraw the Drug, they could have continue to administer the Drug for the patients who were well tolerated and stop enrolling the new patients or adding more checks and balances like more screening additional monitoring while doing the first day administration.
JMHO, something spooked Takeda with Frensius Medical where the issues have occurred and their decision not to rollout further in other dialysis centers despite the positive outcome for the patients who were well tolerated.
I'm unmoved with the day to day price fluctuation and will remain here till the final outcome.
The Drug is coming back and there are no issues on that front, it is just a matter of time.
Will we get any clue from FMS earnings, we will have to wait? AMGN can't undercut the price forever to be in the business. They will have to give up, it is just a matter of time.
iFMS should be more worried, because it is not just the Drug price it is the Labor Cost which they will have to consider, since most of the Medical/Medicaid reimbursements are fixed and they don't have much maneuverability on this front. Omontys will address all of their issues.
I know it is popular just to thumbs down gwp because he is annoying, but you are all fooling yourselves if you believe 1) the recall was voluntary and 2) Takeda can just "change the labeling" and re-introduce O.
The recall was voluntary just the same as any corrupt CEO who "resigns" from a company wasn't actually fired. By doing a voluntary recall, the perception was that AFFY was doing the right thing (which they were) and they being pro-active rather than waiting for the FDA to pull the product before or after another possible death.
Just change the label and all the problems go away? I'm sorry, but that is a very naive way to think about this. I'd also like comment on the quote from onewaytomars2 "FDA never revoked O's approval, so FDA cannot legally interfere in O's reintroduction." Here is how that scenario would play out. Takeda, "We're reintroducing O under a new labeling!". FDA: "No, you're not." Takeda: "Well, you never officially revoked Os approval, so YES WE ARE." FDA: "Os approval is officially revoked." Takeda: "We're suing." FDA: "Good luck." That is not a path Takeda wants to travel. Of course, some of you may think the FDA would be fine letting O back on the market, but this will be after the investigation is complete and not before. What would the FDA look like if they let O back on the market when the investigation on the cause of deaths isn't even complete.
This will be a $5+ dollar stock eventually if O is re-introduced. Remember that the deal AFFY made with Takeda a few months back only gives AFFY at most about 18 to 20% of sales. Takeda is taking all the risk in doing the investigation and they are going to reap the majority of the rewards.