My view of FDA remains that they are a bunch of friggen' dolts.
Even in grade school teachers are quick to note the fast learners and put them in accelerated classes.
But FDA, unthinkable. Put every drug in the same line and they all go thru the same wait, wait, wait BS (of course payola moves you to the front of the line, especially for grants)
FDA already responded to our IND and that was suppose to be some minor matters to clear it up.
One would think you don't resubmit the IND, you just advance the old IND with the corrected minor details so an OK could come about nearly immediately if all matters squared away. But then if we don't have 10 levels of oversight and signing off, we don't have the layers of govt employees needed and the passable deniability to cover those that slow things down for payola or should something amiss happen with a drug. Sometimes the amount of waste in these govt departments and agencies and all things they do in general is beyond even one's wildest imagination. We'd be a lot better off to pay all Congress members $5MM/yr if they would just play fair w/ the American public.
IMO the only saving grace for IPIX is the overseas trial that will put Brilacidin CV19 on the news worldwide. Otherwise, I could see BP winning the day in the USA and burying the small startup with the treatment that will cut them a new one.
I hope IPIX goes w/ a foreign BP and tells US ones to stick it as to the best drug to come down the pike.
Since this started, seems like big medicine is as rigged as Wall St. Oh yeah, they pay big lobbyists as well. Who da thunk?
