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News Focus
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skitahoe

01/31/25 1:16 AM

#746539 RE: DJPele #746538

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
Bullish
Bullish
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LTR

01/31/25 4:00 AM

#746548 RE: DJPele #746538

"As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished."

For anyone that has lost patience, I understand. I am there with you. But please read the above from the last 10Q, and then read it again, and then read it again. You knew we were not going to get updates. If you can't handle the wait, even with being clearly put on notice that updates were not to occur until the final MHRA decision was made, then that is on you. All your frustration and anger should really be on your inability to wait it out, for the process to unfold. The company I am sure wishes things moved quicker as well, but it is what it is. I am not going to start bitching about the company or Linda or anything or anyone else and neither should the rest of you. And please don't respond to this with a litany of gripes because we've all heard them. I am specifically referring to the one topic of the wait for approval or rejection. This IS the process and we were told, "as is typical, and as the Company has previously stated", at the very beginning, and again in the 10Q.
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flipper44

01/31/25 7:28 AM

#746557 RE: DJPele #746538

Agreed, those sections from the ASM should be reposted with regularity.
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RobotDroid

01/31/25 8:33 AM

#746563 RE: DJPele #746538

Instead of reposting old news the inept mute grifters of this company should be talking to SH. But that is just wishfull thinking as it does not happen.
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JTORENCE

01/31/25 9:38 AM

#746573 RE: DJPele #746538

DJPele Why don't you just refer them to the multitude of PR's that they issued with updates to the 10Q.