RE: FDA's "Everlasting Gobstopper"18 Dec 2024 21:20
"Now five indications in phase 1b." Eh? What's that about?
"We will find out soon the identity of the Avacta BP sugar daddy." Eh? What's the evidence for that?
As regards the 'everlasting gobstopper' (surprised they allowed those in the Good Ol' US of A), here's the text from that item:
"The only requirement is that the new product must contain the same active moiety and be intended for the same orphan use as the drug that received the original designation."
To my mind that just means different formulations of the same drug for the same disease(s) - slow release, delayed release, controlled release, liposomes, intravenous, intramuscular, suppository, pessary, inhaler, transdermal, buccal etc, etc (if there are any more routes of administration... suggestions?)
As regards pre|CISION, it's dipeptide precludes any route that involves acid digestion and iv (intravenous) is the obviously the most direct and reliable route of administration.