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10/14/22 7:34 PM

#521994 RE: dennisdave #521984

No one said that Dcvax can be approved for other cancers without clinical trials. But Dcvax may not need P3 trial for other indicators as you suggested. It can file for approval for other indicators with just P2 trial. There are precedents.

Plus Padur tends to bring drastic change in Accelerated Approval. Read his paper, 2030 may not come to your mind again.

https://www.nejm.org/doi/full/10.1056/NEJMp2208954