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Re: biosectinvestor post# 381767

Monday, 05/31/2021 8:43:39 AM

Monday, May 31, 2021 8:43:39 AM

Post# of 732766
This has been a fascinating discussion to read, thank you all especially pqr and biosect!

It is making me think about triangulation and validation. The science validates the medicine which validates the business which is validated by peers and regulators but also by patients themselves.

Here, I see a manufacturing company built around DCVaX, which had the capacity to manufacture thousands of doses being bought by CRL for $875M CASH, and $1B loan being given, for what amounts to 5 years of DCVAX guaranteed plus other contracts. I see this company expanding expertise all over the cell and gene space for a lot less. Swanton/Advent and Fraunhofer validate this process.

I see Mt. Sinai and I see a summary of the science as well as a message about medicine. When you spend a lot of time in one space you find a pattern. A physician compares their experience with their own. They form hypothesis and then conclusions sometimes. Then over dinners at meetings they share those experiences with each other. When they all validate each other, excitement builds. Time continues to validate what they believe together and it has been 4 years since publication. I see Mt. Sinai doing what SNO and the Academy of Medicine did earlier. The science and medicine have already been validated by peers including those who serve on the DSM.

Regulators validate each other as well. EMEA and UK seem to be doing so already. Nordics have their validation in place with LL‘s database so they should follow along just fine. What about the grand old U S of A? Anything validating anything else here? Have other studies been stopped for efficacy by DSM and what array of conclusive steps were taken and doesn’t the mere fact that it is an array validate adaptive design? Doesn’t a model that includes individual case data across multiple entities validate something else? Don’t the regs clearly say that you must? How many regulations and rules and laws and oaths and conventions were at play here? Hypocratic validates Geneva which validates DSM and thus IRB which validates FDA regs, and they all align with no more placebo...it is barbaric.

That would be validation externally, then internally, then externally once again followed by internally once more. All the way around, wrapped in lots of bows throughout business, and science, and medicine, and regulators, and DSM, and CROs, and warrant exercises, and and and and and AND.

And we can build this dream together...

And it looks like there is a lot of greed building everywhere, kind of like I imagine the gold rush must have felt like in the moment. Capitalism thrives during these times.

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