Replies to post #6171 on FDA Plays

[pcrutch]

To me, AVNR traded down b/c of the ALKS/AMLN rejection which everyone thought was a sure shot.(My opinion on that is below.) Investors know this is a binary event which can go either way.

I still believe the SPA with the FDA should help AVNR out. Also, remember this: AVP923 is dextromethorphan/quinidine. Dext is active ingredient in most cough suppressants sold OTC. Quinidine decreases GI AEs.

His secret telephone call told him so. I don't plan to address piano anymore. Tired of his commentary.

{ ALKS / AMLN : I agree with David Kliff,owner and editor of the Diabetic Investor newsletter. FDA shouldve asked for Phase 4 studies if they had more questions. This is not productive for business or patients. Why didn't they bring up the QT studies in the other submissions AMLN did? Very, very odd. FDA has looked at their application multiple times and now they bring this up. It does not add up.

"... Diabetic Investor is now convinced the FDA has lost all touch with reality. This is not paralysis by analysis; this is an agency totally out of touch with reality, which has strayed a million miles from their mission, a mission which states they should use scientific evidence when making their decisions."

"While Bydureon is not a perfect drug, after reviewing all relevant data there is no question the benefits of Bydureon far outweigh possible risks. However, the FDA has once again shown they are actively looking for any issue, no matter how farfetched, not to approve new treatments for diabetes."

"Still there is no excuse for the agency’s action with Bydureon. This is more than a travesty; this is an outright example of how badly our system is broken. Frankly every member of the FDA and those elected officials who are more concerned with how they look on TV should be ashamed of themselves. You can also add to this list Dr. [Steven] Nissen and his followers who care more about remaining in the spotlight than helping patients. [Nissen is a well-known, some would say controversial, Cleveland Clinic cardiologist and outspoken drug safety critic.]

"The bottom line here is the blood of millions of patients with diabetes is now on the hands of the FDA, those fat cat elected officials who care only about looking like they doing good than actually doing good and Dr. Nissen and his supporters who could care less about helping patients and more about being on TV. This entire group should be ashamed of themselves as they do not know the damage they have created and even worse, they could don’t really care. This is truly a sad day." }