Re: Hemophilia Tea Leaves
as opposed to EHA 2021 when PFE presented 1.5 year Hemo A data, PFE did not present 2.5 year data at EHA 2022
and I've seen no indication that PFE will be presenting 3 Year P1/2 data at ASH, where abstracts will be online on Nov 3rd
yes, PFE guided to restart the trial in Q3 and the PR stated it was "re-opened" with dosing expected to resume in Oct... so I guess that means PFE met their deadline... but I'm very curious to hear what they say about it at their Q3 ER on Nov 1st
meanwhile, my thesis that ABR will likely be a trial-buster hasn't changed since ASH 2021 when the excessive bleeding after week 69 was disclosed... a disclosure that required just a modicum of understanding of what the "1.4 ABR for the total duration of the trial" represented, which absolutely was not just "caused by one patient traumas in P1-2 over a year ago"
and I guess you forgot to note McClung's comment today that BMRN had similar F8 over-expression in their trials but they never had a pause, any SAEs, nor any concerns from FDA
so again, I think PFE's full year "pause" was a red herring while the lack of updates at EHA (and likely ASH) plus the unexpected sale of $43M ATM shares in Q2 are anecdotal factors in my belief that PFE will never file a BLA (which IMO would likely be the next trigger for a milestone payment)... and now the >50% of patients already dosed are between 1-2 years follow-up, so PFE must have a pretty good idea how ABR is tracking in P3
so keep digging; you are very entertainng... but you and your "myths" will be exposed soon enough