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Re: abc1212 post# 684112

Tuesday, 04/09/2024 11:29:28 AM

Tuesday, April 09, 2024 11:29:28 AM

Post# of 689574
abc some questions about dcvax + poly-iclc + mhra

Assume DCVax approved tomorrow for GBM -

(1) could UK doctors ADD poly-iclc in an off-label basis?

Although MHRA does not recommend “off label” (outside of the licensed indications) use of products, if the UK licensed product can meet the clinical need, even “off-label”, it should be used instead of an unlicensed product. Licensed products available in the UK have been assessed for quality safety and efficacy.



(2) has the MHRA bumped into poly-iclc before?

Yes - in fact -

https://www.medthority.com/drugs/l-antineoplastic-and-immunomodulating-agents/l03/l03a/l03ax/l03ax08/

https://www.cancer.gov/research/participate/clinical-trials/intervention/poly-iclc

If UK doctors can combine DCVax-L + poly-iclc right out of the approval gate
then the 5 year survival rate for patients with GBM will scare the shit out
of everybody - esp chemo big pharm (i.e. twilight time)

I expect MHRA approval to result in 40,000 gbm cases a year going to
the UK.

Thanks for your post
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