Mar. 19 at 1:07 AM
$GALT Since things have changed lately with FDA’s policies, this is how I see it will play out:
1) Meeting with FDA (Type C) sometime after March 30. KOL doctor, CMO, Doctor Henry Brem, M.D., etc will present the full data readout to FDA.
2) FDA will then return the guidance to GALT management shortly such as:
a) FDA will want GALT to re-submit all the
paperwork to FDA for Voucher program.
b) If Belapectin is not qualified for Voucher
program, then give FDA more time to re-
evaluate all the full data readout.
c) Then FDA will give a final decision: AA with
post study Ph3 OR apply for NDA (don’t
need ph3) for a full approval OR reject the drug
completely.
3) Partnership/ BO will follow. JMO. GLTA!
