Here is some evidence supporting my opinion that OMONTYS will resurface:
When administered subcutaneously (under the skin), the drug works without any serious reactions. Serious reactions have only resulted from intravenous (in the vein) injections.
All three fatalities occurred in a few dialysis centers believed to be owned by the same company, Fresenius (FMS), who has a mound of safety issues filed against it. These fatalities occurred relatively soon after FDA approval.
Takeda may identify post-approval patient reactions that did not surface during the extensive trials, and then the company will need to take definitive and demonstrable steps to remedy those newly identified reactions before any discussion of OMONTYS's return. But this is a highly unlikely scenario in my opinion and experience. The trials were extensive enough to uncover any pattern of severe patient reaction (specifically allergic/anaphylactic). Since the post-approval death rate was 3 out of 25,000 patients, it seems much more likely the cause will be identified as "human error" at the dialysis site. In this case, we could anticipate the immediate return of OMONTYS, with additional warning provisions and enhanced training requirements to be implemented and enforced at dialysis sites.
Patient issues unrelated to OMONTYS may be discovered as the cause or a significant contributing cause to the severe reactions and the 3 deaths.
New patients may have been given too high an initial dose. The severe reactions uniformly arose within 30 minutes of the first dose in new patients only.
The age and/or frailty of the patient may be a significant factor.
The severely affected patients may present with cancer and CKD, for which OMONTYS should Not have been prescribed.
Patients without a diagnosis of CKD may have received OMONTYS, which is Not indicated for these patients.
There may be other dosing factors. See the current dialysis issues involving dialysis products; namely GranuFlo and NaturaLyte. These dialysis solutions cannot be ruled out.
Severe reactions may have been inadequately handled by healthcare givers, or correct procedures may not have been followed, or there could have been contamination of the drug within the facility.
At this juncture, the future of Affymax all comes down to Takeda identifying and correcting the issue(s) with OMONTYS or the actual clinical administration of the drug itself. If it is in fact "human error" or dosing errors, the fix could be as simple as further warnings, a more specific "black box" warning, and/or additional training for dialysis personnel in the potential and remedies for such hyper-reactions, though they were fairly well documented when approved by the FDA.
I want to note here that OMONTYS's fatality rates fall far below several other very popular prescription drugs that have been sustained in the market (including other ESA's). One has to go no further than watching many commercials advertising prescription drugs to hear the (extensive) cautionary provisions of side-effects and potential for death to know that there are many drugs with comparable or worse mortality statistics that have been sustained because the benefits outweigh the consequences which is a main determinant by The FDA for approving drugs.
That's why Takeda is taking their time. They want to protect the franchise. They think like Japanese do, not Americans. Mitsui and Mitsubishi have been around for centuries since the Samurai warriors. They look at it as a strategic asset, not a venture bet.
The more one dwelve into this it becomes much more clear that there is no reason to believe O won't return to the market. FEN-PEN is a treatment for this type of reaction and probably Takeda needs to ensure prior to administering Omontys, that they are tolerant to FEN-PEN and go for Omonty's adminstration in the sub-cutaneous administration.