Dec. 7 at 6:09 PM
$ALT If you don't think the FDA isn't taking a hard look at
$ALT, you're likely not following. Things of "possible interest" for the FDA regarding
$ALT:
1) Placebo in MASH trial outperformed
$ETNB and
$MDGL drug arms. (Note - this board will hype the placebo as being an anomaly, but
$ALT's robust biopsy reads eliminated ANY concern about this. What's presented are TRUE results. Oh, and they failed their TRUE fibrosis Primary endpoint.
2) FDA spent a lot of time money and resources to help
$ALT design their P3 Program for Obesity;
$ALT has since decided not to pursue it.
3)
$ALT has admitted to misdosing in their MASH P2b trial. They did not disclose this at 24W topline readout. Details and FDA involvement is unknown at this point, but this would be of a great interest to the FDA.
4)
$ALT performed an invasive test on a subject unnecessarily. Again, the FDA will be interested in this.
5) Previous misleading claims about Pemvi's benefits for LMP should be of interest to FDA.
Cheers
