Hi Zenox,Have enjoyed your contributions.Its my understanding...

Hi Zenox,

Have enjoyed your contributions.

Its my understanding that the PRE IND resulted in the FDA saying we would need a confirmatory trial as part of our Phase 3. Thus 002 (main trial) and 003 (confirmatory) was so designed. I'm also under the impression that the IND covered both trials and it was a definite stipulation by the FDA that we had to have both. I didn't think we would needed a separate IND for the 003 at any stage? I think its incorporated in our original IND?

Of course the criteria for being able to progress through to the confirmatory is subject to all protocols of 002 being met including (but not limited to) safety standards/monitoring and AE's all being observed etc. Of course there would be formal processes and data reviews/observables that would allow the 002 to continue and the 003 to commence but it doesn't need a formal IND to start 003 necessarily.

Happy to be shown any evidence to the contrary.

I also understand that a separate NDA would be needed before any licensing would be granted not withstanding any accelerated approval (in that case sponsors would still need to continue with a confirmatory trial before full licence could be granted subject to observations both in the real world and 003 data).

The below slide was as a result of their revised clinical trial program, I assume this is what the FDA have approved and was all part of the ultimate IND. Cant see them having to submit a specific, separate IND for the second part of the trial ie the confirmatory. Europe is carrying the majority of 003 from what I can ascertain? Its a done deal.







While I do agree that there may be some merit in doing two tranches of raise which could have an overall lesser dilutive impact over time, there is also some benefit in thinking of 002 and 003 expenses together and being done with any funding gap once and for all at the right time? Many factors here to consider! Of course the potential of any sort of deal (MPS?) would also weigh in.


What would prevent PAR from NOT going ahead with a 003? The only real scenario I can see is a number of distinct failures in 002. Out of some 100,000,000 injections so far, there has been no fatalities. Its safety record is up there. I cant see any other scenario involving 003 not going ahead?


"Approved indications for injectable PPS (iPPS) include prevention of thromboembolism, and the treatment of acute blood vessel occlusions. PPS
has been available as an injectable treatment since 1949, with over 100 million performed doses, and no reported serious adverse events (AE’s)". ¹




My thoughts







Ref
1) Baker & Young Feb 2021 Research Report