RE:RE:RE:RE:RE:RE:RE:RE:RE:NEW POST IN LIFE SCIENCES
four, 1st off this MB is a lot saner now that the pumpertrasholes have moved on to the agorascam MB and left reasonable investors to chat..
..my thoughts on your post are this:
...the FDA is mandated by law to only approve drugs that have successfully completeled two well controlled confirming trials, etc. with only specific exceptions that are determined on a case by case basis (it is in various FDA documents)...this was i believe an outcome of thylidmide and CoX inhibitors ??? where many thousands of innocents were killed, harmed, etc. by corporate greed (chance, bias, misuse, fraud, abuse, etc. are simply unacceptable to the FDA)
..IMO 208 and the intended use don't meet the exception rule (for instance, unmet need and catastrophic consequences) and neither ASSURE nor ?? meet the critierion of a well controlled trial as the endpoint, etc. was not the same as BoM and i believe one of the issues is "long duration" use and impact
..i suspect both Europe and China have no such legal standard to meet (and shame on them if they don't)
..now 208 can get approved both those places but i doubt together they equal 1/3 of profit potential of the US and additionally each EU country has to actuall approve for use (which i understand is a long boring administrative process with lots of pressure on price)
..so i suspect that if RVX gets a voucher and sells it they will very shortly start a 2nd BoM trial in the US (and i have seen at least one baby biotech run two exactly the same PIII trials at the same time to meet the FDA standard)
...without FDA approval and just based on BoM the value of RVX is IMO somewhat limited particularly given the $68M debt needing repayment in a couple of years
ps the FDA has a wealth of info regarding its expectations for approval, jkj is an ace sleuth i'm surprised he hasn't combed the FDA site for this info. (it is why i hold many of the opinions i hold)