Joe K, I hope you found this one interesting as well. I know I did!
Was looking at the Activ-3b primary EP and it looks very favorable for us.
The primary ep for NRx trial was very difficult to hit even if the issues with regional hospitals didn’t happen. It was a binary ep of recovery of respiratory failure followed by mortality (another binary event) although they where able to change to odds of survival. Neither in our favor.
We know Aviptadil had a 10 day LOS reduction across all patients and sites. Highly Statistically significant. That is basically what the NIH end point is with more definition which imo will help even more.
Recovery, assessed at 90 days [ Time Frame: Thru Day 90 ] Recovery categorized as 1 (Best): At home and not receiving new supplemental oxygen for ≥ 77 consecutive days; 2: At home and not receiving new supplemental oxygen for 49-76 consecutive days; 3: At home and not receiving new supplemental oxygen for 1-48 consecutive days; 4: Discharged from hospital but either not yet home or home but receiving new supplemental oxygen; 5: Still hospitalized or receiving hospice care; 6 (Worst): Dead.
So this fits perfectly into Aviptadil hands for great success. The patients who get better will get better faster. This EP should show high stat significance with an exceptionally run trial.
I know we all want the EUA but the results from this study are 6 short months away! These results will change the course in pulmonary medicine imo. It will be peer reviewed and published immediately. If the FDA screws around and throws out a denial it could be the greatest opportunity for cheap shares you could ever find. I know it would suck and I hope it doesn’t happen but I do believe 2022 will be a massive year regardless.
Also keep in mind Javitt is trying to get a bio marker approval for IL6 reduction. This program allows for a streamlined approach to multiple development programs with the same drug. So if approved they don’t need new endpoints for other indications. They just prove IL6 reduction which is huge. Here is a study on COPD that shows the effect of IL6 with people with COPD.
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