Hi
@Kingtup,
I think you're recalling CEO Itescu's comment, in response to Edward Tenthoff's (Piper Sandler) enquiry re a placebo-controlled study.
That comment by Itescu was to the effect that there was no 'point' in having a placebo i.e. no justification for a placebo-controlled study in the 'targeted group' i.e. the group which MSB proposes to target in the upcoming study.
CEO Itescu then went on to explain to Mr Tenthoff that, in this SR-aGVHD group, there was no significant prospect for survival under any & all therapies available as SOC (standard of care). And so, there would (both ethically & in terms of clinical logic) exist even less reason for a physician to suggest the use of a placebo, as any form of trial/ study control.
As I've written previously on HC: MSB, my belief is that Mesoblast intends now to conduct a non-randomised, interventional study using an external control
prospectively approved by the FDA. I expect the proposed control to be set out in an SAP produced to demonstrate prospectivity of control selection to the FDA's biostatisticians & tendered to the FDA no later than the Type A meeting for the FDA's comment and acceptance. IMO my own research indicates this approach may very well produce the "
controlled data" which MSB has stated the FDA has required in the terms of the recent CRL.
Lets see if I'm on the money. If I am I'll buy you a beer, & you can let me helm that Saona 47 while you drink it.
Cheers,
GLTAH
(20min delay)