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Monday, May 08, 2023 8:11:18 PM
Also, using any of those in the process of making the DCVax-L that was used in the Phase 3 trial will be approved.
Agreed. And in my opinion (and it would seem, your's), the manner in which the dendritic cells were activated in the P3 L trial would be the method presented in an MAA and what the regulatory agencies would base their approvals on. And the DCs were generated using GM-CSF (granulocyte-macrophage colony stimulating factor) and IL-4 (interleukin-4). I'm not sure if ATL is thinking that the P3 trial may have used Poly ICLC at come point in time... but since that agent was never part of the protocol, it would never have been used with any of the P3 patients.
Now if and when DCVax-L is approved, I'd think physicians could use Poly-ICLC (I believe it's approved for use) along with DCVax-L in combination if they felt (or it's born out) that it would aid in the treatment process.
I think we're on the same page on this topic?
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