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nidan7500

02/25/19 3:57 PM

#183001 RE: jimmy667 #182992

Well, Dr. Aisen should certainly be informed and one would expect his influence would help AVXL be visible at least. After many years of field interfaces w/FDA and others I can say many are strong talented people but they also have some complete AXXholes. I sat in a closing meeting one day with a female FDA Investigator/inspector w/Consent decree, she put her .38 cal revolver on the table and conducted the meeting. I have seen them rush and spread out from an opening meeting intentionally rushing ahead of the escorts to get evidence from peoples desks. But on the other hand they are lousy jobs and a lot of people will try to lie to them. I have conducted 3rd party medical device/pharma investigations after the FDA has left w/o finding N/C and found very basic/serious issues which should have closed the doors. Some really good people but a lot of not so good. They make mistakes like anyone else.

Unless there is a concern about his credentials/specialty and scope of knowledge and assuming no concerns over conflict of interests, he should be a beneficial resource for AVXL, IMO.
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Talon38

02/25/19 3:57 PM

#183002 RE: jimmy667 #182992

Jimmy/Nidan....agree with the assessment that with Paul Aisen joined with Tayo Fadiran and Frederico Goodsaid who are alumni of FDA/CDER, we should have a good chance to be one of the ACTC's first picks.

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From an earlier post

"Regulatory Pathfinders. Federico Goodsaid, Phd collaborated on our CTAD presentation. He has both FDA/CDER and Pharma (VERTEX) background and certainly must have been a compatriot of Tayo Fadiran at CDER. Would you want to bet that those two are are working with the FDA on a precision medicine AD trial, perhaps under ACTC. Read Goodsaid's insights into precision medicine drug development and designing modern trials at Regulatory Pathfinders website.