2023 The Final Countdown, page-53

Timeline Update

FDA recieved BLA resubmision for GvHD on 2Feb23
FDA announced PDUFA date of 2Aug23
GVHD approval decision 2 Apr 23 to 2 Aug 23 ( 2 - 6 months for fast track*)

*Zanubrutinib - a drug for treating mantle cell lymphoma, was approved over 3 months ahead of its PDUFA date, late in 2019, along with at least onother 4 drugs, all approved earlier than the PDUFA date given by the FDA.
Crizanlizumab-tmca approved 2 months before PDUFA in 2020.
Voxelotor accelerated approval three months before PDUFA.
Givosiran 2.5 months before it's PDUFA date.
It is not a given that the yes / no will occur on the actual PDUFA date.
Source : https://endpts.com/fda-approves-5-new-costly-drugs-well-ahead-of-pdufa-dates/

CLBP trial commence by mid 23
Source : https://hotcopper.com.au/threads/ann-msb-q2-financial-results-and-operational-highlights.7254868/

CHF FDA most direct path forward ( AA ? ) Q2 - 23
Company is considering smaller groups - the most severe patients or limiting the treatment group to those that benefit the most.
Source : https://hotcopper.com.au/threads/ann-msb-q2-financial-results-and-operational-highlights.7254868/