Adu Subramanian

I wrote about regulatory flexibility in December and Peter marks was a key player. I write about his departure and the impact of FDA layoffs now. TLDR: It’s bad right now. People at the FDA, Investors, and Biopharma Companies face uncertainty. But biotech and the FDA be okay in…

So is it time to just mega long every binary that may hit stat sig but question over meaningfulness. Boy do I have a list for you VYNE topline almost cerrtainly positive LRMR only biomarker and safety spin coming FULC Also biomarker but where is the data QURE topline cUHDRS…

Still think this is very interesting data $CELC in 2L ER+/HER2-/PIK3CA WT, 9.3m Geda triple by IV But does it look like a population currently occupied by $AZN Enhertu? DestinyBreast-06 2L+ HER2 ultralow: 15.1m PFS with Enhertu IV mono Which one will you choose?

$celc pubmed.ncbi.nlm.nih.gov/38703285/ hmmmm "lower than Phase 1b safety" means < 80% stomatitis FYI

$CYTK $BMY Full MAPLE-HCM results will be presented August 30 at ESC (already hit primary). Key Catalyst imo 1L treatment for HCM is beta blockers. Significant % patients are well controlled. Mavacamten (Camzyos) is second line in guidelines and requires beta blocker step…

Peak

$qure interesting they might 1) 0 evidence of target engagement in humans 2) no placebo controlled data 3) selective disclosures 4) an early safety signal .....but still be a long because of one data cut and FDA agreement

Worst case scenario for $MLTX's SLK (IL-17A/F nanobody) at #AAD2023 this weekend: BIMZELX (IL-17A/F mAb) significantly underwhelmed vs expectations in HS on HiSCR50/HiSCR75. izokibep (IL-17A small kDa mAb) results are ambiguous due to more mild patients enrolled.

$QURE Can we explain the placebo increasing over time between 6 and 12 months? Technically, getting a sham injection would be better than both high dose and low dose over 12 months........

$CYTK am I an idiot or did $BMY not run a trial against beta blockers in the 1L settings? With MAPLE, is it possible payers are more lenient on Afi instead of requiring step therapy, thus positioning ahead in the restrictions. Maybe not just because they are generic, but bull…

A single arm Onc trial…..With this leadership? drugdevletter.com/p/how-to-read-… “Step one: does the trial have a control arm?” - Vinay Prasad

A trap to new bio investors is to start a thesis with "if". No if. Always ask this combo questions: to your best knowledge, - what's probability of if - what's probability of else

Yes I did, not enough of course. My 5% position pales in comparison to the balls on the other bulls