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Old 04-11-2020, 10:42 AM   #87
MAXUM
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I don't have exact numbers on this - even if I did and could disclose them it would be from the context of the trials that are run by my employer which are a fraction of what drugs are currently under development at any time. In fact we specialize in the oncology space as a general rule. There is specific genetic experimentation going on right now in cancer treatments that may prove useful in many other areas including antivirals such as COVID. Those are actively being looked at.

That said, I do know that the entire process from start to finish is extremely long and drawn out, and the number of drugs that actually make it through the entire process is very low - I'd say less than 5% based on my observation. Thing is while so many may fail, coming out of those failures is new treatments that are tweaks or reformulations of a prior study. Most people don't realize that it takes a lot of time and expense to get drugs out there with relative confidence they are safe and behave as expected. We have some trials that are 15+ years in and still not approved. Most average about 10 years.

What does help ALOT is that we conduct trials all over the world and it is really helpful to do this work in countries where the regulations are far less stringent, as that data can be aggregated in and helps with the FDA approval process in the US.

As a general rule the FDA is a pain to deal with and arguably some aspects of approval to move a drug forward through the development process are overly cumbersome and frustrating to deal with at the same time there is a lot at stake considering people could and in some cases have died taking experimental drugs. How do you really weigh being overly cautious with providing a risky treatment that could save a life?

Just as a disclaimer I'm a systems guy not a doctor or scientist. The above information is based off conversations I've been privy to or just being part of the process in setting up or shutting down trial related studies or providing data to the FDA as a drug is tracking through the process. I am by no means an expert on this. I just know the regulations are insane, and not just the US either, the EU is even worse.
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