$RLFTF DD by Vader69 (copy) So, I’ve been stal
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Posted On: 12/25/2020 12:09:49 PM
$RLFTF DD by Vader69 (copy) So, I’ve been stalking the NeuroRx Linkedin Team to do some sleuthing. I ran across an old job listing from Sept 2020.
https://www.linkedin.com/jobs/view/assoc-dir-...049022439/
What’s interesting about it is the description of their two clinical trials:
“Our P2/3 Aviptadil study (144 patients) could lead to an Emergency Use Authorization. This study is in a critical phase, and your participation will be essential. An additional study(ies) in earlier patient populations, with an inhaled form is in the planning stage.
Our P2b/3 SPA study of ~150 patients is the only study required for approval for our first indication. Therefore this role requires an experienced "hands on" clinical operations professional that is excited about working at all levels.”
We know the 144 patients was increased to 165 patients at FDA request. What is the SPA study? This can’t be the inhaled trial because estimated enrollment per clinical trials.org is 288 participants. Is it the EAP trial that has also continued to enroll?
Also of interest, three new hires related ot
Heather Lothamer, October 2020, Senior Manager Clinical Operations
Jeff Heckman, October 2020, Senior Director, Alliance and operations Management, Manage and direct key external Alliances, provide expertise in all aspects of drug development and commercialization.
Stephen Ma, November 2020, Associate Director Projecti management CMC and Clnical Supplies
mapping of drug manufacturing to align with drug supply chain for clinical trials and commercial sales
randychub -
SPA - this means they have already had a meeting with the FDA to design the trial endpoints and if the trial meets those endpoints the drug will be approved. It is a smart thing to do in that it prevents a company from running a complete trial and than having the FDA say the trial design was not complete enough and forcing the company to then run another trial. SPA = special protocol assessment
https://www.linkedin.com/jobs/view/assoc-dir-...049022439/
What’s interesting about it is the description of their two clinical trials:
“Our P2/3 Aviptadil study (144 patients) could lead to an Emergency Use Authorization. This study is in a critical phase, and your participation will be essential. An additional study(ies) in earlier patient populations, with an inhaled form is in the planning stage.
Our P2b/3 SPA study of ~150 patients is the only study required for approval for our first indication. Therefore this role requires an experienced "hands on" clinical operations professional that is excited about working at all levels.”
We know the 144 patients was increased to 165 patients at FDA request. What is the SPA study? This can’t be the inhaled trial because estimated enrollment per clinical trials.org is 288 participants. Is it the EAP trial that has also continued to enroll?
Also of interest, three new hires related ot
Heather Lothamer, October 2020, Senior Manager Clinical Operations
Jeff Heckman, October 2020, Senior Director, Alliance and operations Management, Manage and direct key external Alliances, provide expertise in all aspects of drug development and commercialization.
Stephen Ma, November 2020, Associate Director Projecti management CMC and Clnical Supplies
mapping of drug manufacturing to align with drug supply chain for clinical trials and commercial sales
randychub -
SPA - this means they have already had a meeting with the FDA to design the trial endpoints and if the trial meets those endpoints the drug will be approved. It is a smart thing to do in that it prevents a company from running a complete trial and than having the FDA say the trial design was not complete enough and forcing the company to then run another trial. SPA = special protocol assessment
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