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Thursday, January 30, 2020 11:17:07 PM
The fact that the FDA has come out with these guidelines demonstrates the direction they would like to go and the thinking they will use in reaching determinations. The FDA seems to be using these guidelines and may continue to do so in spite of ad hominem opposition. It just makes sense. In the end, if the FDA wants to approve, they will find a way. The guidelines indicate their current thinking going forward. NWBO does not need to wait for formal adoption of the guidelines. It is enough now. JMHO.
Hopefully, the delay in announcing the ASM is a harbinger of good things to come.
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