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Re: EnergyFundies post# 250952

Wednesday, 03/06/2024 6:58:09 AM

Wednesday, March 06, 2024 6:58:09 AM

Post# of 252302
I believe (don't know for sure) when they are blinded, they are walled off unless there is a safety problem although others on this board would have better knowledge on this than I.

Having said I don't really know I have a few comments about Viking and then one anecdotal note from another.

  • Viking seems "walled off" even more than most if that is possible. They are a company of only 27 people per the last annual report and heavily use third parties contractors to help them with trials/ manage sites conducting trials. While I'm sure VKTX management and key employees monitor their contractors, it is an extra layer.

  • The particular trial of interest right now is the phase 1 Oral. That trial is being conducted at a single site in Australia. You might say it is walled off from Viking in San Diego by the Pacific Ocean.

  • I held a position in Arena pharmaceuticals before it was acquired by PFE. They were conducting a trial for Etrasimod (Velsipity) in Atopic Dermatitis during covid. They had a site in the middle of the trial stop treatment for several participants because they had lowered lymphocytes. (The drugs MOA was to lower lymphocytes!). The dermatologists at this one site and not any other were concerned covid as that also lowers lymphocytes even though the participants had no other covid symptoms. (they should not have stopped treatment according to Arena management) At the time Arena management had no clue for several weeks that this had happened and I believe was criticized for not monitoring their sites. To be clear, my point here is not about etrasimod or covid but rather that companies are walled off and don't really know what is going on at the sites they have but I think they are supposed to monitor for major problems/safety issues.

    I'm curious what others know here. Please comment if you have anything to contribute as to what contact companies can or should have with trial sites when they are blinded to the study.

"People are best convinced by reasons they discover themselves"

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