RE: Re:No it wasn't13 Apr 2017 07:49
Are you purposefully being dense and twisting my words or do you genuinely not understand?
OXP fulfilled many clinical trials over the past 3-4 years.
These trials were setup to identify the formulations ability to reduce/remove GI irritation.
These trials were presented to a regulating body (MHRA) which was accepted.
The trials used the most recently recognised measuring system of Lanza scores.
Given the trials were performed as per requirement, with the most up to date techniques, and accepted by a world leading regulating body, OXP felt it was confident the FDA would also accept the data.
The FDA want a trial that gathers MORE data. So when you say "OXP didnt know it needed a trial and thats normal is it?" you are severely exaggerating the point I am making.
Let me also tell you that through some research other GI meds currently approved didnt have to get bleed rates like OXP is being asked of.
There isnt a magical list of things which the FDA explicitly says will guarantee you an IND.
All medicine is different and many need bespoke data.
This is WHY these types of FDA meetings are held so you know what to do next.
OXP has cash, ii backing, and ONE trial to perform to meet FDA expectations.
There are many pharmas on AIM worth multiples of OXP that need 5+ trials before NDA and commercialisation.
Also the trials are more than likely going to pass because it isnt groundbreaking unknown medicine where you could get bad trial data.
Its better formulated medicine.
Again, the FDA asking for BETTER DATA, than is currently held, is not new, and is common.
Stop exaggerating the point I made.
We still have OTC, and if FDA offer them an IND to commercialisation for reduced GI irritation for OTC they should take it as it will be direct revenue.