New Player, page-44

Woha this thread has turned a camel sort of brown color, sorry I am late to the game and do not care what anyone's history is, or posting thoughts are because it is all subjective and frivolous to me. If you have an axe to grind your problem, simple get over it. To carry on about someone's previous posts indicates a low level of investment risk profile. FFS if your pissed because it aint what you signed up for tell your hair dresser seriously.

On a more serious note in the last quarterly the inept highly paid folk who run this piss poor biopharmaceutical company said ........

"Paradigm met with US FDA on the 10th of January 2024 to discuss outstanding requirements for the next stage of the Phase 3 clinical program in Osteoarthritis. Paradigm’s clinical and regulatory teams have filed the response to the Type D meeting with the US FDA containing updated nonclinical and clinical data to the Agency as well as the proposed clinical trial protocol utilising 2mg/kg twice weekly for the next stage of the phase 3 OA program. The response package to the US FDA was submitted as directed by the Agency, through a request for review pathway. The request for review pathway does not have strict Prescription Drug User Fee Act (PDUFA) Agency response timelines. Paradigm OA clinical program has FDA granted Fast-track designation and the feedback through this review pathway is typically received within three months.

Can anyone confirm what this means because I have tried to research the 'Request for a review pathway" as mentioned by Par and it is not mentioned anywhere I can see in the multiple sites that outline the FDA approval pathway. Maybe this is part of the process of FAST TRACK Approval, but I cannot see this term referenced and the MD or CEO what ever he is said 3 months, it is now 6 months and no announcement as to whether they have received the response? what the F? Mr Renny FFS tell us what is going on?

Happy Days enjoy your Sunday Coffee and remember be nice it costs zip.