Ryoncil: ODAC/FDA Meeting Discussion, page-6

So I thought I’d give my prediction for tonight’s vote. I expect all doctors who work with aGvHD or those who represent patients/consumers to vote in favour and 3 members of the ODAC board to vote against. From a total of 10 votes, I expect Mesoblast to earn 7 votes out of 10 (with a +/- 1 vote margin of error).

Expected votes in favour:
1. Jorge A. Garcia, MD, FACP: Distinguished scientists tend to be a bit more lenient (not recklessly).
2. Anthony D. Sung, MD: Works in the Adult Blood and Marrow Transplant Clinic so should understand the need for better treatments in paediatric SR aGvHD patients
3. Nancy J. Bunin, MD: Is a paediatrician so understands the need
4. Naynesh R. Kamani, MD: same as above
5. Mark C. Walters, MD: same as above
6. Diana L. Pearl: Is a patient representative so will like the efficacy and safety profile
7. Sandra Finestone, PsyD: Is a consumer representative so will like the efficacy and safety profile

Anticipated votes against:
8. Susan Halabi: As a biostatistician/bioinformatician she might see something she doesn’t like
9. Christian S. Hinrichs, MD: Has his own interests in cellular therapies and therefore has more detailed knowledge and might demand more information about the more technical aspects of remestemcel-l
10. Philip C. Hoffman, MD: I wasn’t sure on this pick. He has a lot of publications in high ranking journals, but I’m leaning towards him being extra critical of mesoblasts application

Disclaimer: This is just my opinion, feel free to disagree. I expect 5 votes at a minimum tonight. GLTA