banter and General Discussion, page-4765

"So, if there is a delay, to SI's "expectation" I won't be getting overly upset, even if we don't find out until after 30 Sep. It is potentially poor shareholder communication,"

Tell you what.

I'm content with what the company has announced.
I expect they probably have submitted or will over the next couple days.
I also don't expect there must be an announcement tied with the submission - Although..... If the loan facility is linked to submission, then there may well be an announcement when the milestone is hit.... but I don't even know if that is a 100% iron clad requirement either - because they allready said they were submitting, and that has no bearing on the companies balance sheets etc.....

If they release on 1st Oct that there is a delay, and they did not meet the estimate.... fine.

If they release in November that there was a delay.... poor shareholder coms IMO.

I'm starting to think JB's potency test recombinant is the problem here - not the assay as the " words " are matching the " words " used by MSB employees. FDA admitted some of the the GVHD001 potency assays results had issues - and that the older results did not. That does match up with a logical change in the testing antibody used for GVHD001, which then gave different reading for GVHD 001, but thanks to the other manufacturing quality improvements, the cells in fact worked , but the potency tests did not correltate.

Rose also mentioned getting hold of recombinant for assay testing as one of the delay reasons....

FDA said it looked reasonable......

MSB said data is in hand, and they are in line to resubmit.

I cannot see this as being the reason for not resubmitting.

I think it will happen Q3.