HiAll,Justwanted to express my gratitude to OP; Imascientist &...

HiAll,

Justwanted to express my gratitude to OP; Imascientist & Zenos for sharingtheir info re the upcoming readouts on the DREAM HF-1 trials.

Weare at the pointy end so good luck to all. I’m looking at MSB continuing itsproven long history in delivering on its safety and efficacy trial experiences.. in the case of CHF & CLBP ..we are using the very powerful MPC’s.

RegardingaGVHD , great news that MSB have submitted request for Type A Meeting – apositive in itself !

Weare ALL hoping that responsibility and intellectual honesty prevails this timeround.

Our Backstop: (IMO)

Ihave looked into the dispute resolution process where FDA may not accept/agreeto Type A meeting.

Thenext step for Meso would be to request a review by CENTER FOR BIOLOGICSEVALUATION AND RESEARCH (CBER)

Inchecking this out, I was very buoyed to see the Head of CBER is Peter MarksM.D., PhD - DIRECTOR @ CBER.

Followingis some information around Peter Marks M.D. PhD.

1. The 1^streference is in in relation to PeterMarks MD. PhD, quitting Operation Warp Speed, just days after joining the program in May - because “he did not want to feel like he was a part of a political team and thought his talents would be put to better use at his FDA position “.

This director of CBER appears to be of thehighest integrity.

https://www.beckershospitalreview.com/pharmacy/fda-s-vaccine-head-quits-operation-warp-speed-days-after-joining.html

2. Peter Marks M.D. PhD.BIO.

https://www.fda.gov/about-fda/fda-organization/peter-marks

Extract:-

“Following this, he completed an Internal Medicine residencyand Hematology/Medical Oncology fellowship at Brigham and Women's Hospital inBoston”

Inspeaking with a good medical friend of mine , Peter Marks M.D. PhD iseffectively a Transplant Physician J

3. See conference below - Alliance for Cell Therapy Now (September 2019)

PeterMarks M.D. was joined by many speakers – none other than the eminent pediatric Transplant Physician Joanne Kurtzberg, MD J

http://allianceforcelltherapynow.org/wp-content/uploads/2019/09/Bios-for-Event-Final-09.18.19.pdf

With the above in mind, I am confident thatProf will tirelessly pursue ALL avenues and will not flinch - until Ryoncil becomes an approvable treatment for pediatric patients.

GLTAHand enjoy the weekend.
Anjo.