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Friday, June 09, 2023 12:29:00 AM
I agree. The pathway for them is approval for GBM, and expansion of the label, which is now very easy given new regulations. Why would they create a massive, novel bill to climb for themselves by going for an “agnostic approval”. That doesn’t even make the vaguest sense from a regulatory perspective. It’s not going to happen.
But validation of the MOA is a critical piece of the basic approval. It will be very compelling and sets the stage well for the next approvals and expanding the label rapidly, as rapidly as is practically possible.
Thanks for the great, careful post.
But validation of the MOA is a critical piece of the basic approval. It will be very compelling and sets the stage well for the next approvals and expanding the label rapidly, as rapidly as is practically possible.
Thanks for the great, careful post.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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