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SkyLimit2022

01/17/26 10:34 AM

#809937 RE: Investor082 #809934

zero82,

It’s not “simple.” Commercial-scale manufacturing of a novel cell-based autologous product is not simple either…

We will let the FDA decide what is “approvable” & determine where unmet needs exist.

FDA NEWS RELEASE January 12, 2026


DCVax®-L BLA
Bullish
Bullish
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Doc logic

01/17/26 10:45 AM

#809939 RE: Investor082 #809934

Investor082,

So tell me why you expected approval by end of May in 2024. Was it because you were expecting a manufacturing Update about a GMP approved Flaskworks prototype which is what Linda was expecting to have to announce at the June 2024 ASM? Now you know why I believe manufacturing progress for sustained commercial viability is key to approval and my revenue projections. As proven by your mistaken guess on approval, you are only guessing as to when that manufacturing piece of the puzzle will be fitted into the picture. Based on the hints given at this last year’s ASM that piece should be ready before the end of June which is approximately 2 years since the failure of the previous prototype to be found fit for purpose. This is a reasonable amount of time for a new engineering firm not tied to original creator Sashi Murthy to take an existing previous prototype and make it GMP compliant which is what should have happened last time. Looking forward to that update; ). Best wishes.