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Monday, May 08, 2023 7:02:31 PM
However, if it is approved at the same time doesn’t validate your formulation. I also have made the argument that the company may get it approved at the same time as part of the same process as an adjuvant.
I think you’re just continuing to mix things around, patents, FDA approvals, formulations, maturation agents and adjuvants, as if they are all the same thing.
Also, using any of those in the process of making the DCVax-L that was used in the Phase 3 trial will be approved. That’s kind of obvious. But the side trials where it was then included as a separately delivered adjuvant into the arm of the patient, that will require the approval that could come at the same time, as I said, but requires additional process and bureaucracy as well as the participation of the manufacturer if it’s not already approved.
Regulatory processes and laws are really complex. You have to understand the different concepts, why they are different, why they are not all connected and then look at the regulatory process and how it applies to the various items separately.
It’s not one big mashup.
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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