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Re: eb0783 post# 260667

Saturday, 04/02/2016 7:07:06 PM

Saturday, April 02, 2016 7:07:06 PM

Post# of 347009
Eb0783,

You seem to be confused as to the role of the FDA. My comment was that it would have been prudent for PPHM to rerun another phase II trial was based on the best use of its capital. The phase II trial was corrupted, had a small number of patients and a high number of dropouts. It would have been prudent of PPHM to rerun the trial instead of scaling up and spending a boatload of money on a gamble. I was proven correct as the trial was stopped at the first look. The FDA doesn't care if companies waste their money on long shots or weak premises. Both Sunrise arms had Docetaxel, and no obvious safety issues were known by adding Bavi so the FDA wouldn't block the trial.

As far as Garnick, it is irrelevant what he said since he was proven wrong. Besides, the company decided to move forward. Did you expect him to say anything less than glowing and keep his job? So why hasn't he stepped forward to express his confidence in Bavi now? where is he hiding?
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