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Re: DJPele post# 746538

Friday, 01/31/2025 1:16:28 AM

Friday, January 31, 2025 1:16:28 AM

Post# of 817841
Thanks for the reminder DJ, it pretty much lays out a lot of what we'll see in the future.

One question that really I feel uncertain about is the ability to make the improvements in DCVax-L and put it immediately into a Phase 3 trial.

In other companies when changes were made the product received a different designation, and they started all over with a Phase 1/2.

I believe that we'll get approval with DCVax-L as it is, it's fine to improve it, but I suspect it will get a new name like DCVax-L2.

Believe me, I hope I'm totally wrong, if all the regulators agree that the change incorporated by the new technology doesn't require such trials I'll be thrilled, I'm going by what I saw IMGN need to do in trying an improved drug. That was decades ago, so perhaps things have changed.

Gary
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