Yer right , as though you have no idea of the company or the trial that I was referring too despite holding shares in it . CYP cohort B shows a clinicl response at 3 days .
Now as I asked you yesterday and the day before.
You have a child that has a bad blood test. Data suggest about a 20% chance of survival . Decision is made for Remestemcell-L to be administered as the product has been deemed safe and the child has more than 3 times the chance of long term survival . I should see a response within 3 days and blood test will confirm that response at 7 days , that will confirm that my patient is very likely to survive long term. Would you not think to take action ,report and demand another batch of Remestemcell-L if a response was inadequate?
Now we may not agree that MSCs provide rapid response or that our therapy even works., it should not be a concern to the FDA as the Dr would be concerned if he had not observed a clinical response at day 3 and a blood test would be taken at day 7 to confirm ether a negative or a positive outcome.
The reasons for the FDA concern over potency assays have gone from been significant at time of the ODAC meeting to now a fairly minimal concern.
DO YOU AGREE?
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