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Dr Bala

09/07/22 10:25 PM

#511882 RE: HyGro #511875

Confounding after a highly successful P3 trial is an impossible task.
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SkyLimit2022

09/07/22 10:39 PM

#511885 RE: HyGro #511875

I think I know what you mean in reference to the FDA . The FDA approved the trial to resume in full force after its halt.

The FDA and NIH work very closely together. Highly reputable licensed professionals have vetted the immunotherapy research of Dr. Liau, I would recommend that you research and study for yourself the recent 590 million dollar grant that was awarded to UCLA. The U.S. government NIH grant is funded by tax dollars and is public record for anyone who wants to see it. Within its many many pages, you will find many professionals who have reviewed the immunotherapy work of Dr. Liau.

The NIH peer-reviewed grant is the source of funding being used today to dose patients with DCVax-L and Keytruda.

https://clinicaltrials.gov/ct2/show/NCT04201873

Department of Neurosurgery Chair Linda M. Liau, MD, PhD, MBA, was a leading recipient of NIH grants – No. 3 in the nation within the discipline.

“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful and hopefully will lead to future treatments.”

The NIH is a much better source than I am or that anyone on social media is or anyone on a stock message board. Researching the peer review of a large recent government grant is an example of research that is more reliable than a stock message board is. Anyone can go look at the grant for themselves and review the professional vetting of its recipients.

NIH and the FDA tell us that they are well-coordinated they assert that work closely together on the development of new technologies.

https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
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biosectinvestor

09/07/22 11:25 PM

#511904 RE: HyGro #511875

No, that was addressed by the appropriately addressed update to the Statistical Analysis Plan (SAP) which was filed with regulators for final approval before data lock, and while they were still blinded, as per the relevant regulations, contrary to your constant false assertions.

The fact that too many patients that were placebo wanted the drug and it was considered ethical that they receive it, and that PFS, only a proxy for Ongoing Survival (OS), was discarded because if the way the drug works and how it made it difficult to diagnose recurrence when the drug causes inflammation of brain tumors and distinguishing that from recurrence was not possible at that early time in the trial. So they went not with a hoped for proxy for OS, which often does not predict extended OS, but actual OS. It took way longer to gather that data and did not just happen by accident, as you seem to asset, ignoring that they let the trial go for 18 years, from 2002 to 2020, to get survival data.