Totally agree Aug. And 3 years to finish a tiny, tiny phase I. 18 patients or whatever it was.
If that's the track record to date- then year 2020 IMO is the fastball track. Phase II is not unusual to take 1 to 2 yrs or so minimum. A large, good sized well run FDA level Phase III? Not unusual in the slightest to be 2 to 3 yrs from start to "first data" let alone the compiling then of the data, the writing of the FDA submission (which isn't some 2 sided form to be filled out) but looks like a small text book when submitted- 100's and 100's of pages long typically, an enormous undertaking.
To have this complex a process involving the human eye just blown off as some "slam dunk done deal" now just cause they crossed the first baby step of a tiny Phase I is IMO folly.
This company has a long, hard and expensive road still ahead to get near even attempting an FDA submission, let alone the holy grail of an FDA "approval". The biggest and the best of "big pharma" who have legions of expert staff, entire departments dedicated to just "FDA regulatory affairs" and near bottomless money/cash hoards- they fail to get most of their initial drug "candidates" ever approved. That's just the reality of it.
Here's an article or two on what it costs and takes now days to get ONE DRUG/complex medical process FDA approved- these are from "think tank" and industry group research firm numbers- it's daunting:
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