Hi RickyH,
May you ask @Pooslice what his credentials are and why he believes he is more of an expert than the many distinguished professors, scientists and medical doctors that were part of the ODAC committee, since NO ONE on the ODAC committee expressed any of these issues. Specifically, can you ask him which year he won his nobel price in medicine?
From the FDA's line of questioning, there is concern around:
An absence of multi-factorial combination analysis of other factors influencing cytokine responses
Such as? The ODAC committee expressed no such concern during their discussions.
Inability to describe how and why exactly the mechanism by which immunomodulation actually occurs
Mesoblast explain the MOA, FDA thinks the MOA is more complicated. The regulations for cell therapies only require you to know at least one possible MOA that is measurable by at least one quantitative assay and one qualitative assay. Treatments where the MOA is not known are still approved if they show clinically meaningful responses. MOA can be used to inform the requirement of needing to satisfy the "potency" requirement for product approval. The alternative is demonstrated efficacy, where the ODAC committee voted 9-1 in favour of efficacy.
Refer him to Mesoblast's slides:
https://www.fda.gov/media/141132/download
https://www.fda.gov/media/141133/download
Inability to describe exactly how MSB can rigorously ensure treatment consistency/potency.
ODAC expressed no such concerns.
Refer him to Mesoblast's slides: https://www.fda.gov/media/141132/download
Inability to describe something simple like how long the treatment actually exists in vivo
ODAC expressed no such concerns.
Refer him to the webcasts for the ODAC meeting.
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