Hi,
The one thing I got from the webinar is that the chances of an FDA acceptance of new potency data is not totally out of the water...but being somewhat skeptical these days will believe it when it happens.
Wonder too if the potency assays are not acceptable would that also not mean whatever a trial's result without an FDA acceptance of the quality and consistency of MSB stem cells it still wont be approved?
What I mean is if you cant guarantee that each patient is getting the same product it would be hard to approve?
cheers
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