Does PoC have a good side?I have no desire or care to be on your good side PoC. The fact that you react to my post the way you do speaks of your character. I have no more info, background or opinion on the FDA issue to add here. As to chronic care or life threatening unmet need......diabetes/cardiovascular disease are chronic diseases and they are life threatening, so why not both?
BDAZ
PoC wrote:
"
hey bearskin, if you want to get back in my good book, here is a challenge for you (which BTW will help all owners)...WTF is up with the non-FDA thingy, it is very quizzical...here are my thoughts:
a) is BoM diabetes or cholesterol??? and what difference does that make in FDA world???
b) is BoM chronic care or life threatening unmet need??? that makes a big difference IMO
c) ????
and i say this as best i can tell the trial design seems pretty SOP by FDA standards..event based, adaptive, long duration, etc.
ps still like to see 208 as mono but hey there you go"
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