Re: Tweet from Prof Kausik Ray
in response to
by
posted on
Jun 02, 2020 11:13AM
Right on golf ... "was it over when the Germans bombed Pearl Harbor?!"
"Shoot for the moon, if you miss you're still among the stars" ... fight for every inch of "logical" ground. If we cannot achieve immediate NDA review/approval (with or without P4) thru a logical cogent mutually beneficial and "systemic" argument and position, then "maybe" a highly favorable and shorter P3 is the worst case result?
People are humans too ... except at the FDA?! ... never let the facts (and SOP/protocol) get in the way of the truth. Especially in critical times, with safe potential options, answers, and possibilities. In a typically B&W environment, our situation is a shade of gray, but a very noticebale and attractive shade of gray ... "if" you are more concerned with progress and solutions, rather than hiding behind conservative protocols (which also have their benefit though, primarily revolving around "safety" which does NOT appear to be a concern).
Haha, just my position and opinion about it, which is only worth a cup of coffee with an additional $5 (these days) ...