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Re: flipper44 post# 527680

Friday, 11/04/2022 7:37:08 AM

Friday, November 04, 2022 7:37:08 AM

Post# of 689210

Didn’t NWBO say they could not be assured the endpoint change would be accepted in their 10k. Is that something can he can fall back on? Was anything stated about new endpoint acceptance before May 10, 2022?


Flipper,
I doubt it. Same language here:
Form 10-K
For the fiscal year ended December 31, 2015

In addition, the endpoint against which the data is measured must be acceptable to the regulatory authorities. The primary endpoint of our Phase III trial of DCVax-L is progression free survival. Sometimes regulators have accepted this endpoint, and sometimes not. There can be no assurance that the regulatory authorities will find this to be an approvable endpoint for Glioblastoma multiforme cancer.


https://www.sec.gov/Archives/edgar/data/1072379/000114420416088301/v433750_10k.htm
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