In this 57:30 audio from Danny and I, we first discuss Glycomimetics (GLYC), and the slip up the company CEO made at The TD Cowen 43rd Annual Health Care Conference (AML board). The slip up can be found at the 11:50 mark (link) where The Ceo says "We have disclosed that in the phase 3 388 patient trial, that we are seeing north of that number (30% transplantation rate of the original P1/P2 trial from 2017) which suggests the Upro Arm to be upwards of 40% transplantation rate, which is 2 to 1 over the historical. The CEO then goes on the say that The FDA is "aligned with us" in terms of allowing the company to "capture the benefit" of transplantation in the current Median OS driven RR AML trial. This leak strongly suggests to us that The FDA has already agreed to add/change/amend the protocol of the RR trial to include transplantation in relation of MRD-Negativity as an acceptable endpoint for registration. Based on this, Danny and I now believe the company will submit a rolling NDA straight-away including the NCI frontline study = 2 studies = NDA and not an AA. We explain the company strategy by going over all publicly available information for us to disseminate.
We then continue in the audio to discuss both $RETA's situation with it's current approval and the current $SVIB fiasco and why we don't think it will be a systemic issue at this time.
This audio is nearly an hour long and takes careful listening, especially to understand our view on GLYC and why we think they will be a 'big deal' in The overall Leukemia setting and a first-mover so-to-speak.
Audio below, enjoy!
Scott
