Replies to post #34453 on Revive Therapeutics Ltd (RVVTF)

[tripmcneely]

The only emerging situation is boosting as many people as possible so Moderna and Pfizer can make their billions

[Ecomike]

The bulk of the trial data, 500 out of 710 people is still locked up and no one has seen or analyzed that data, in total.

Thus the FDA has very limited data. So how are the delays the FDA's fault?

Limited funding small firms, must crawl, before the walk, and walk before they can run, and use every $ they raise wizely.

The big Biotechs can burn 10s of millions of dollars and never notice it.

[rickstereo3333]

Pr from Sep 28, 2022

However, the FDA has advised the Company to submit a meeting request to discuss the appropriate endpoints and justification of the relevance of the revised primary endpoint. As a result, to potentially obtain FDA agreement and strengthen the relevance of the revised endpoint, which relied upon the Study’s Pre-Dose selection data, the Data Safety Monitoring Board (“DSMB”) will review the completed Post-Dose selection data of approximately 500 subjects.

The 710 (Pre 210 + ?Post 500?) p-data has long been scrubbed and prepped for analysis so as it stands, your criticism (and mine) of the fda's apparent dawdling is totally valid.

They have been in possession of the 210 pt-data for several months, so IF same was insufficient to render the ep change decision they could have, IMO, long requested the remaining 500 pt-data to come to a decision but curiously havent.........WHY???

Not very clear on the technicalities or intricacies of the ep change process (anyone with insight into same???) but, again IMO, this seems unnecessarily excessive.

This apparent inaction only reinforces my evidence based OPINION that they apply their rules and processes selectively for the sole benefit of a certain ""group"", which by every definition is 100% corrupt!!!