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biosectinvestor

12/11/22 3:42 PM

#547496 RE: HyGro #547491

These comments are absurd typically given that the peer review is serious and many points you've made are just not even relevant and are straight up factually false, e.g. post hoc, data dredge, etc. However, I am glad to see you have conceded that "it may get approved".

Looks like you're learning that this ongoing false light narrative is failing.
Bullish
Bullish
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SkyLimit2022

12/11/22 3:59 PM

#547501 RE: HyGro #547491

Thanks for your comments about the FDA regulatory advisory.

The approval of murcidencel does not depend on one clinical trial, nor does it depend on one regulatory agency. However, if you wish to focus on the FDA, there are countless reasons to be confident of murcidencel’s forthcoming FDA approval.







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

https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter



Additionally, there are also countless reasons to be confident of approvals abroad. For one example, Dr. Ashkan serves as an advisor to the U.K. Government.




https://www.uspto.gov/about-us/news-updates/uspto-announces-cancer-moonshot-expedited-examination-pilot-program




https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

Bullish
Bullish
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dstock07734

12/11/22 4:42 PM

#547510 RE: HyGro #547491

HyGro,

First of all, knowingly submitting manipulated data to FDA is a crime that can incur civil or criminal penalties. If what you said were true, which is completely false in my opinion, the reputation of the co-authors and of Jame Dignam responsible for reviewing statistic analysis would be in jeopardy. In Wall Street, the evil doers may come together conspiring something bad like the eight defendants NWBO brought suit against. But I don't think in the medical field, those best neurosurgeons would agree data manipulation at the risk of patient's life.

As for partial hold, everyone knows what caused the partial hold. Partial hold from one perspective reflects the fact that FDA is monitoring clinical trials real time. Does this mean FDA knows the data on the combo trial of DcVax plus poly-iclc and the one mentioned by Linda Liau last week? Is this supposed to be good news?