He has made comments around low N values
Because I'd seen that figure prior to the second CRL and had studied it I recognized it again in the patent application.
There were 54 patients in the MSB-GVHD001 study -some three of those got old style product bringing the number down to 51. I found and posted prior to the second CRL public domain stuff from ODAC and from a Kurtzberg paper that got that number down to 25 (they didn't have serum levels for more than 25 - which is a fact you don't deserve to have shared, again, - and then lower again to be some fraction of 25. That gets pretty damn close to the 11. I've covered this before the second CRL it just didn't register with the hype crowd here - that's still here mostly - biasing the board now as then.
Do you agree?
No
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-1024
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