MSB to dispute FDA finding in Type A meeting, page-390

@ddwn The information below seems to suggest Mesoblast were aiming for full approval and because of this did not request accelerated approval. I'm still not certain whether the FDA considered accelerated approval, but Mesoblast's response tends to suggest that they didn't (maybe because it wasn't part of the original request?)

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

A drug that receives Fast Track designation is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

• More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

• Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

https://www.globenewswire.com/news-release/2020/02/03/1978576/0/en/Mesoblast-Submits-Completed-Biologics-License-Application-for-Ryoncil-to-US-FDA.html
Mesoblast has requested Priority Review of the BLA by the FDA under the product candidate’s existing Fast Track designation for SR-aGVHD.

https://www.globenewswire.com/fr/news-release/2020/10/01/2102679/0/en/Mesoblast-Receives-Complete-Response-Letter-From-the-FDA-for-Biologics-License-Application-for-Steroid-Refractory-Acute-Graft-Versus-Host-Disease-in-Children.html
"As there are currently no approved treatments for this life-threatening condition in children under 12, Mesoblast will urgently request a Type A meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a post-approval condition for an additional study."