RE: FDA1 Aug 2019 16:56
back now and have spent a happy half hour reading comparison.interesting to note that statistically the FDA review process for drugs (as opposed to devices)is actually quicker overall than EMA.unfortunately in this context "quicker" is a very relative term and our particular holy grail is still some time off.that said as each month passes the time for FDA approval draws closer(apologies for stating the obvious) and as I've mentioned before when we get to 2020, 2022 will start to feel much closer.im afraid that to my cost i do have a passing acquaintance(no more) with the FDA process having been invested in motif bio which has recently had a very turbulent time. to me as a layman the outcome there certainly seems to bear out the FDAs concentration on the safety aspects of new drugs as a prime determinant of the approval process outcome which seems to have outweighed the putative beneficial effects of the antibiotic under review there.in the case of fortacin i would not expect there to be any safety concerns and regardless of the suggested difficulties of establishing "bothersomeness" as a recognisable concept of substance to support the application (my interpretation of what has been said before so apologies if not technically accurate) i would feel relatively confident of a successful outcome to the FDA process (EMA approval must on a simple level indicate this is likely) so hope fully its just (ha ha!) a question of time and money to get there.what may happen in the meantime is, of course, anyones guess.on a more prosaic note aussie tax due today. news awaited.