TGD spent a bit of time explaining how 2-73 can "prevent" diseases from ever happening-that in animal models that received the drug for 7 days in a row and then injected with the disease never showed any signs of acquiring that disease-TGD says-paraphrasing-"it is important that all should be aware of this"---IMO very powerful comment !!!!! I realize this "prevention" is a long way off
Thanks plexrec for observing/noting and posting this critical point.
After decades of assessing WW QMS regulatory and ISO systems used in pharma and medical device WW operations (conformance-compliance) I agree totally. Where effective corrective action requires the identification of root cause. We must then prove efficacy of corrective and preventive action taken as follow up. These must also include establishing monitoring systems needed to avoid-prevent recurrences through ongoing assessment of/for systems efficacy. All of that will/must force investigation of any contradictions when the system is functioning effectively in a closed loop manner. (BTW-that is a system regulatory requirement.)
Happy to see that Dr.M. is pointing out the process flaws in existing control systems. BTW, this line of reasoning/processing can lead to a lot of money being spent monitoring for things that rarely occur, which is likely why it does not happen as much as it should.
IDK if other micro-bio-pharma companies have the guts to even dare to go down this path very far. BUT, When we own a company where top leadership does these things then (IMO) we know we are in the right place.
Saw the recording and found it reassuring to see how far we have come with the S1r science and clinical data in the last couple of years and they way additional data is collected to contribute to elucidating the role, function and capabilities of the S1r.
Dr. M. presented really well and sounded extremely confident, comfortable and centered.
I'm confident we can get Rett approval A2-73. Anything beyond that is, for me, icing on the cake.