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1234jklm

01/23/20 9:41 PM

#114030 RE: oldmusky #114028

We wish Dr Crabtree all the best and especially good health

And thank him for his continued belief in this technology which is now just weeks away from ind submission.

What an amazing achievement it will be for him and all of us to have the ind accepted and approved and clinical trials started.

And have the chance to achieve breakthrough therapy after the first few patients. (cytodyn have just applied for breakthrough therapy after trials in just two patients)

If the BTD is granted, it will fall under one of three subcategories that (A) address a serious condition with poor outcomes for which there is no Standard of Care (SoC), (B) provides substantial efficacy improvement of a well characterized SoC for a serious condition with poor outcomes, or (C) provides substantial therapeutic index advantage over a well characterized SoC for a serious condition with poor outcomes.

If a BTD is granted, the possible outcomes are (A) conditional or full approval, (B) expedited development, (C) rolling submission, or (D) review shortened.



A please.

Can you imagine how wonderful it would be to achieve breakthrough approval for this technology just a couple of months into the trials.

2030 will be an incredible year.

Can you imagine how much a diabetes treatment using ciab would be worth after fda breakthrough approval for pancreatic cancer?

History in the making.

We wish you all the best Dr Crabtree and thank you for all your hard work and belief which has brought us to a stage where we are potentially weeks away from enlisting our first patient. What a triumphant cap to your already illustrious career this will be.

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dealerschool2006

01/23/20 10:31 PM

#114033 RE: oldmusky #114028

I inherited shares of PMCB, waiting for a nice run up...