Exactly...
Its obvious it’s the first rodeo for most people writing commentary here. When the panel questions the structure of your trials it’s an instant no. There’s no point going any further.
They’ll be required to do more trials at the very minimum, assuming they’re given the chance to do so.
The FDA is heavily resistant to stem cell treatments, just look at their track record of approvals (or lack thereof). If anyone thinks MSB has done anything to improve that then you really need to sell your stock and read the data from a more neutral perspective.
Ryoncil: ODAC/FDA Meeting Discussion, page-854
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