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News Focus
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SkyLimit2022

12/13/22 1:22 PM

#548324 RE: HyGro #548315

Thanks for your opinion—Yes, the FDA is always circumspect in their decisions, and the FDA does not consider disinformation posted on social media.

Beyond the significance of years of clinical survival data from three separate clinical trials, there are two other crucial factors to consider before approval can be awarded:

1. Safety Profile/Benefit-Risk Analysis
2. Unmet Medical Need





Then, perhaps further consider its use in combo based on interim survival data:






fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track" rel="nofollow noopener noreferrer ugc" target="_blank">https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track




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

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


Bullish
Bullish
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Roman516

12/13/22 4:26 PM

#548424 RE: HyGro #548315

Just an opinion!
DCVax-L data is valid and will move forward.