Quote:CA is moving away from every part of CYDY that had a 'hint' of NP associated with it and is sending a clear message to FDA they are resetting and listening to the regulators w/o any NP influence. This is a bold move and I believe is a very good move as this further puts CA actions as verifiable actions --- what the regulators ultimately would like to see as a vote of CYDYs seriousness of recognizing the sins of the past.
If the depth of the GCP/GMP gaps were proportional to the way the clinical studies were performed by Amarex (+CYDYs lack of proper oversight) and Pestel had some (or complete) level of understanding of these deficiencies I can understand why he led the 13D charge. At the time the attempted take-over was frustrating; However, I couldn't blame that team if they knew what we knew now. They believed they were doing the right thing IMHO.
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
I wanted to re-post this reply I got to this post by Pharma-Junkee. This man is very experienced in validation and documentation with the FDA. He knows of their rules and regulations and knows how they enforce them. I respect him highly.
My question is does any one think Pestell knew of Amarex's failings and could that have been the reason why he led 13 D?
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