MSB 2022 - The road to commercialisation, page-1384

I'm glad we've now got something else to discuss other than speculating on our limited understanding of the Assays.
I concur with @dplane and like to thank @dachopper for his awesome posts, here is the summary from the MVest webinar overnight - https://hotcopper.com.au/posts/62545611/single

"Our number 1 catalyst is that we are targeting resubmission for GvHD this quarter."
Start the count down to 30 Sep 2022 - Ryoncil BLA re-submission by this date... but, you would think we would hear more news on this leading to the actual re-submission.

We are getting closer to commercialisation - unfortunately, one inch at a time
Hopefully, this webinar is an indication that the company is ready to accelerate the progress - "laser focus" and all!

Tick tock tick tock - bring it on!
GL MSB'ers


BTW - I wonder what is the official extension date that Mesoblast have requested to the FDA for the Ryoncil BLA re-submission

From https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110
(c) Failure to take action. (1) An applicant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section. For an application or abbreviated application, FDA may consider an applicant's failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application. FDA will grant any reasonable request for such an extension. FDA may consider an applicant's failure to resubmit the application within the extended time period or to request an additional extension to be a request by the applicant to withdraw the application.