1. Not all deaths happened last night. The company must be knowing of deaths from the day very first death being reported may be in december - january and since then they must have been looking closely to these cases as soon as they happened, and they are ready with a plan B by now (may be they have started executing plan B, and this recall is the first step of it)
- refer the Feb 12 Bio CEO presentation, slide no. 18, ''...Actively evaluating Omontys use data..''
- i believe they are well prepared for these unfortunate situation
2. the company may identify what's causing the death in just 0.02% patients (or allergic reactions in 0.2% patient), develop a pre-therapy diagnostic test that will tell which patients are likely to have serious adverse reactions and then simply exclude those patients from Omontys therapy
3. they may opt for ''tolerance test'' or ''upward dose titration'' regimen= starting with a very low dose, analyse the response, and gradually increase the dose (exclude those who have side effects at low dose) thereby minimizing chances of death - examples: Methadone and many other opiod drugs
4. Omontys may not be the sole cause of deaths and adverse events,
-Fresenius devices also are in question for serious reactions since long ,
- medical negligence
- health status of those patients at the start of Omontys therapy
- etc. etc.
- so overall contribution of Omontys to side effects is further diluted
5. I believe the company is very concerned about the patients and shareholders, and possibly they are doing their best right now to protect both, they released the RECALL on SATURDAY,
-A total RECALL - stopping therapy even to 99.5% patients who are responding very well
- SATURDAY- providing enough time to analyse situation, thereby preventing longs from Panic Selling. Had it been released on Friday or Monday i may not have thought of all this possibilities and typed all on message board
6. I believe they have solid things/steps in place to back up a recovery from this disastrous looking scenario, c'mon this drug works pretty well in 24950 patients out of 25000 ! so the drug isn't a poison, god loves human, and soon there will be ways created to bring this important medication back to the patients
those who agree, please support. Bump the post with your thoughts so that we can inform every long out there seeking help
the game is not over
from REMS review of omontys on FDA website
''..During the 2008 period, death occurred in 88,620 ESRD patients..''
ESRD= end stage renal disease
we can't blame solely omontys for the five deaths
Losses or gains aside, this drug was of benefit to many. Just as the 5 deaths are important, also the beneficial effects to the 99.98% that tolerated well. The drug needs definitely a second chance and although it may be a risky or even a bad investment in the coming weeks/months I do hope that they find what went wrong and find ways to minimize the danger and be able to offer it for the benefit of patients.
Good post alternatepatel, specially #6.
i know this is a disaster, but i dont think its as massive as most would perceive
as i said earlier, there is no doubt the stock is going to take a nose dive, but i would hold on for the Conference call
even FDA would agree that this is one drug that, if reaches to the right patient in right manner, makes the life much easier