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Re: yoyo88 post# 7119

Saturday, 05/25/2013 6:15:10 PM

Saturday, May 25, 2013 6:15:10 PM

Post# of 426473
Yo...Yoyo88, I occasionally pop over to Adumb Twitter, but have found he will not debate. You make two great points, why the heck would the FDA require an outcomes follow through? Because the FDA recognized the science and want answers to the BIG question, does this save lives and healthcare dollars. Do you think Amarin would spend $50 million dollars a year to do a study they didn't HAVE to do? Hell no! Hence the 40% enrollment and staggered approval Marine-Anchor-REDUCEIT. I agree, "incentive", is the only reason for the requirements and staggered approval here. Ethically not such a great idea, if REDUCEIT results hit it out of the park how many people did we knock off by an inefficient approval. (The FDA allowed 1000's to suffer with Swine flu outbreak, not allowing quicker access to Peramivir and inhalational Zanamivir)

How dare you label Adumb as "irresponsible", are you implying he's OK with people suffering and dying by crushing a small biotech and delaying treatment? If you are, I also agree. DNDN, BCRX, ARNA, AMRN....the list is loooooonnnng. I can spot loser biotech treatments from a mile away, but I'm generally not going to bash them unless provoked. (VVUS).

As far as Herper making a comment, "Nissen's generally opposed to approving new drugs w/o outcome data so I'm not sure his stance predicts FDA", Adumb must be crushed his boyfriend disagrees.

Williams
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