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JFR161162

02/19/24 6:33 PM

#673161 RE: skitahoe #673158

« CO, while essentially I agree with you, I put the odds of approval at over 90% only because of some of the other errant decisions I've seen from the FDA before »

1- company has filed a MAA approval in the UK. Not in the USA…

2- The UK desperately need new cancer therapies since the UK ranks 22 out of 29 comparable countries in the world for survival of brain cancer.
By not approving DCVAX or by asking more trials will kill their ambitions.

3- The UK is in a recession never seen in decades and its withdrawal from the euro isolates it from research credits.
They see the opportunity to create a mini silicon valley dedicated to immunotherapy and can’t afford not to approve DCVAX soon.

4- people live longer with no toxicity.

Cheers