banter and General Discussion, page-10449

“Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. “ - see bottom of said report.

Says it all. People are mostly unaware or uneducated about the changes in key FDA personnel, changed org structure and beefed up resources, better and more focused attention post Covid from the top down and bottom up, and much better engagement by the company with the agency from the bottom up. They are similarly unaware of the shifting and evolving regulatory stance towards a first-in-class treatment, which has been clearly demonstrated in much clearer and more specific industry guidances on cellular products in things such as potency testing. The latter, we all know, coincides with the company’s progress in seeking acceptance of the latest resubmission (we can all see this effort in just seeking acceptance having been redoubled in the 9 months to early July), and in being combined with GVHD specific treatment guidance and what the FDA would have heard from senior Bone Marrow Transplant Clinical Trial Network officials, it speaks volumes about a much more motivated agency in having one very hard, long look at the application (which “after further consideration” was considered sufficient etc etc) in its totality. Often, in regulatory land, there are requests for data to bolster the case for approval. (I say this because I joined one such organisation, albeit in a different industry, after leaving the buy side, towards the end of a long career.) There is sufficient buying from internal people that matter (chair, CMO, regulatory advisor/board member) compared with all the reports based only on what meets the eye, to make me comfortable that this was one of those cases. My opinion only - the corporate communication has become vastly improved on what are inherently complex subject matters. Of course the acceptance of the resubmission, the review period and actual decision on whether or not to approve, are all still pending.

Do your own research.