I can’t take credit for this but copied from ano
Post# of 148286
We hit the Primary and Secondary end points in the 350Mg trial. It was confusing because they reported different ways of breaking it down.
Our Biostatistician believes
BTD +
Phase 3
will be a go.
Covid Critical:
Meta-Analysis was approved by USFDA.
Therefore, the US and Brazil can likely combine trial data. Interim analysis will only be 50 patients. Sounds like we might only need half enrollment in the US, but take that with a grain of salt. Last I checked there were over 25K in the US for critical in ICU.
mTNBC
Sounds like we had 28 patients that showed 12.5 months survivability. We now have about 2-4 more months and could potentially still get BTD, when we re-apply.
“Right now, partnership for our Nash, it looks very very solid”
I think the company should start the mTNBC Phase 3 trial and only apply for BTD just to stick it to Gilead.
Since it sounds like we did the BTD well, we just need to verify the patients are alive, we should apply for Brain Metastasis BTD and NASH.
And close that Nash partnership asap if it wasn’t already closed, considering he said it was looking “solid”
We sent the data to over 1,000 big pharmaceuticals. I don’t remember us ever reporting we sent our data like that, and also getting an independent perspective.
Keep your head up