Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-240

Apologies if already posted.

You will recall that in the 26 Feb 2020 Q1 Earnings Call, Louise Chen from Cantor Fitzgerald asked Silviu about a possible Adcom Meeting for Ryoncil. He replied:


https://www.********/earnings/call-transcripts/2020/02/27/mesoblast-limited-meso-q1-2020-earnings-call-trans.aspx

At the time I had a read about Adcoms and thought I posted but mustn't have.

That same day Eli Lilly was having a successful Adcom (vote 6-5) for a drug Cryamza. Afternoon session.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-26-2020-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02262020-02262020#event-materials

The Lilly "Event Materials" are instructive. Whilst our "Event Materials" tab is (at the time of posting) empty, ie not publicly released, no doubt the FDA and the Committee will have had the Mesoblast Briefing Information document for some time now. The document follows a standard format:

1. Executive Summary
2. Background and Unmet Need
3. Product Description and MOA
4. Regulatory and Clinical Development History
5. Clinical Efficacy (Trial Design and Results)
6. Clinical Safety
7. Patient Reported Outcomes
8. Benefit / Risk

I can't wait for its release in the next few days. It will read as poetry. A milestone in a lifetime's work

Also no doubt Mesoblast will have had for some time now the FDA Briefing Information document. And the opportunity to address any issues. This document also follows a standard format:

1. FDA commentary on the above subjects
2. Regulatory interaction between FDA and Mesoblast
3. FDA Review Issues
4. Issues for Committee

For all the reasons mentioned by others, FDA will be supportive but testing. I agree it won't be a walk in the park. A whole day has been set aside for the meeting. As Silviu said this is "new platform technology". But Mesoblast will know and address each pressure point, thanks to benefits of a professional relationship with the FDA, respectful of the process and with the highest integrity. Bring on our next approvals.

The agenda for the meeting also follows a standard format:

1. Call to Order
2. Opening Remarks
3. Mesoblast Presentations
4. FDA Presentation
5. Questions to Presenters
6. Open Public Hearing
7. Committee Questions/Discussions
8. Committee Vote

After revisiting this material, I have the Master's (@ecoool2) words echoing:

"The FDA has seen all of this before and will give it the regard it (contrary submissions on the public docket) deserves – they have a panel of actual experts who have used Ryoncil (or Rem-L) who will testify. The approval will be given based on the science, the data, the results and the testimony of experts and their patients – not some anonymous but “interested citizen”. It’s worse than pathetic. They should really be ashamed. I didn’t know people could go this low and naked greed takes my breath away – but it won’t make any difference to the hearing."

GLTAH!