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LakeshoreLeo1953

08/31/20 12:02 PM

#268088 RE: Investor2014 #268081

Hell Fire, damn....

Another fact based opinion.

What was that earlier best wish?

XenaLives

08/31/20 12:04 PM

#268089 RE: Investor2014 #268081

I was not talking about "rare" side effects. 10% and up is common.

Cytochrome P450 enzymes were first discovered in 1955. They have a huge impact on pharmaceutical uptake and response. When reviewing my medical history it's obvious I have an issue with drug metabolism but the first doctor to mention them to me was dadofmarcmax. None of my physicians has ever broached these issues despite my history of drug intolerance.

These variants could easily be studied by Pharma, but they aren't.

It is causing millions of people to have poor response or even life changing toxic reaction to current medicines.

Case in point - there is an issue with hydrochloroquine and P450 mutations that can be fatal. It occurs in people Europeoans and Africans descended from people that lived around the Mediterranean and Hasidic Jews and the rate is estimated at 10%. It is rarely mentioned even with all of the publicity this drug is getting.

This is wrong.

nidan7500

08/31/20 12:23 PM

#268097 RE: Investor2014 #268081

2014

Until then hard to see how we could do without randomised controlled trials and not least in rare diseases.



Trials are processes, no more no less. Processes get validated. Many, many unique precision methods should be considered, particularly for rare CNS diseases.

In fact we have seen patents (processes) submitted by AVXL using tools-methods which can easily be applied in such cases. The extreme overhead defined by FDA for trial protocols may be excessively expensive overkill in many unique CNS disease cases. Process validations are key.