The Lady Who Can Tell Time. Currently Taking Care of My Chicken, I am that "fuckin Michelle on Twitter"
Nov 29, 2021 • 9 tweets • 4 min read
$BYSI has a PDUFA on Nov 30 for plinabulin +peg in prevention of CIN
I think this is likely a CRL
Aside from the numerous red flags (changing trial design mid-trial, not enrolling US patients, changing presented data), I'm not sure any of their results are clinically meaningful
$BYSI On the surface, their data looks ok. But based on prior drugs, the important endpoint is DSN (days of severe neutropenia) in Cycle 1, as that correlates with febrile neutropenia incidence
The Ph3 plin combo in TAC patients showed 1.2 days of DSN vs 1.5 days on peg alone
Mar 18, 2021 • 11 tweets • 5 min read
Okay, might as well ask some questions for $FREQ longs:
Link to patent: patentimages.storage.googleapis.com/1f/4b/8f/186fc…
$FREQ 1. In the paper, they say at Day 90, 4/15 FX-322 treated ears had a 10 dB improvement at 8000 Hz, while no placebo showed this level of improvement.
That sounds great! But that doesn't mean placebo patients didn't show any improvement
