RE:RE:RE:RE:RE:WELCOME TO A NEW BIO-PHARMACEUTICAL COMPANY! >>These FDA requirements on the CMC data reveals how insanely bureaucratic that operation is<<
bepando while I do not disagree with what you said here, it remains
the same 'bureaucratic' FDA that will decide whether or not the re-submitted BLA, if/when it is accomplised, by Prometic (under the 'new' management).
It is also
the same 'bureaucratic' FDA, that will ok every IND, give feedback on type C meeting, ok every trial design/give green-light to the trial to go ahead, finally to give approval for every BLA or NDA of every drug developer that ever submit their application.
So far, Prometic has taken 2 decades to come this far and is imo far from being ahead of the peers in term of knowing/meeting the FDA's requirement.
For example, GLPG's IPF drug candidate is now in two phase 3 trials (
see link here ), when 4050 is sitting on the shelf, waiting to go back to do a placebo-controlled phase 2b (when 4050 was cleared to proceed with its pivotal trial by the FDA in September 2017, according to Prometic).
GLPG is also a clinical stage biotech, but they have many important partnerships and are said to never go below $1B USD at any given time in their cash position.
Prometic may have a successful future, but the
risk of not succeeding is under-estimated to the peril of any investor, current or new. For anybody who does
not care about the intergrity of the management/BOD and concludes that the refinancing represents a new/greater opportunity to invest, perhaps you should not forget that
competence also matter!
And on the suject of competence , I see
no material change from before the refinancing (i.e. no new talents hired from outside).