Please Google on “Withdrawal Assessment report for Omontys”
25 April 2013, EMA/419554/2013, Committee for Medicinal Products for Human Use (CHMP), this is a 65 pages report from European Medicines Agency (EMA).
At page 49 and following, there is very fair, clear & detail background information on “newly emerging safety issue”. I believe this is very detail information about Omontys’s serious hypersensitivity reactions. Investors on AFFY either long or short should read this report to better understand this issue.
The Applicant has initiated several lines of investigation in order to identify the root cause of the serious hypersensitivity reactions, including fatal reactions, that have led to the withdrawal of the medicinal product in the USA. The Applicant should elaborate on such root cause analysis including quality, non-clinical, clinical and epidemiological approaches.
The Applicant should also elaborate on the measures being put in place to mitigate the risk of serious hypersensitivity reactions, including fatal reactions, in patients treated with peginesatide, with special attention to patients with multiple cardiovascular comorbidities.
"“newly emerging safety issue”."
Obviously there was a "newly emerging safety issue." If there wasn't there would have been no deaths nor those reactions. Do you mean newly discovered since the february pull or the same old, same old?
Bought some more a bit ago at .82. But then i do have both ctic, and fnma, among many others, so i was feeling a little bit happy, enough so that i violated my next planned purchase at 50 cents. If it ever gets there. Did lower my next projected buy accordingly though. Let's see if i stick with that projected target price or purchase prior to reaching it, again, if ever.
Hi, Godwinpeak, thanks for your comments.
Fatnusss, i am not Godwinpeak.
I believe this 65 page report from CHMP/EMA speaks heavily on everything. I really recommend whoever has a chance to read with open mind. Issues like this involving FDA/CHMP/EMA will not be resolve within 6 or 9 months. It will take whatever times if ever who knows.
"Issues like this involving FDA/CHMP/EMA will not be resolve within 6 or 9 months."
If it's the same issue, not a new issue, about 10 months have already passed and you are not telling me anything new. I have been noting the same thing here for about as long as i've been here.
The biggest problem i do find with this one vs the other companies i get involved with over a disappointment and a plunge, is omontys is their only hope. That's all. Makes it more risky for me to play than most i do, but i like the odds.
I might also add that the report is highly critical of the clinical studies that supported O's marketing application such that they may be unreliable. Moreover, the report questioned the paradox of PEARL studies showing O unsafe for "healthier" nondialysis CKD patients and EMERALD proving O safe for the sicker CKD dialysis patients.
"...highly critical of the clinical studies that supported O's marketing application such that they may be unreliable."
How different a regime did they follow, other than once monthly instead of multiple weekly, than amgen followed to receive approval for its products?