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To infinity and beyond!

07/16/21 5:32 PM

#365607 RE: To infinity and beyond! #365606

Leo and FDA fiddle while the world burns? Someone knows the truth. And it ain't good news for IP

Minnesinger

07/16/21 5:47 PM

#365608 RE: To infinity and beyond! #365606

To the contrary: it might prove quite meaningful...

60 day follow up is meaningless.



The purpose behind the 60-day follow up is to determine/measure Brilacidin's efficacy against the so-called long-haul symptoms.

If there's a statistically discernible and beneficial distinction between the treatment and placebo group with regard to long-haul morbidity (presuming the treatment group shows a lower incidence of symptoms), it would be a significant data point.

I recognize that all of the outcomes in the trial protocol are measured through day 29, but if there's clear and irrefutable benefit conferred through day 60 amongst the treatment group it won't be ignored.

ferdinand_ the_ bull

07/16/21 6:37 PM

#365614 RE: To infinity and beyond! #365606

FDA Seems To Think 60 Day Check Important

https://www.fda.gov/media/137926/download

Page 11 of the download