RE:RE:RE:The More I Search, the More Mind-Boggling the Adcom's Decis
damn, IMO the FDA was very supportive of TST's data and package, my point was if they are not they will let you know in no uncertain terms...that is what you get from FDA briefing documents, they did their independent work and came to the same conclusion
..AdCom is a different animal and i again state that to me the FDA was supportive of MCNA even in the AdCom meeting (as a comparable tune in on Nov 24 to watch them destroy BMRN)
...again my read on AdCom is somewhat different, there could be conspiracies, etc. but i never buy it as it is simply unprovable and unactionable...IMO it was simply (but severely important) a messaging failure from TST and i blame that on the lack of having the COO or CEO/CSO as a formal member of the team and i suspect they simply miscalculated (they perhaps thought it would be a discussion focussed on 301 only and not a wide ranging jump into the rabbit hole (was that Alice in Wonderland, Malice in Blunderland or some combo) that got away from them