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ATLnsider

10/17/23 1:08 AM

#641425 RE: FeMike #641422

FeMike, it is only 1 application. The same application that is submitted to the MHRA, would also be submitted to the FDA, and to any other Participating Orbis Partner (POP) country.

The only point I clarified is that NWBio (not the MHRA or the FDA) would have to submit the application to the FDA, and to the other POPs.

So, once the DCVax-L regulatory application is completed and submitted to the MHRA, and it is accepted by the MHRA, and recommended to the FDA for the Project Orbis program, then NWBio would be responsible for submitting the same application to the FDA, and to any of the other POPs.
Bullish
Bullish