Credit to my69z off another board:
Maybe LH news Monday.
394 data within few days.
The new slides show both as Phase 2. That is huge.
Very important on R&D $$$ savings. Huge.
Dr. Kelly: looking @ other indications beyond Covid with
Philippines. This also explains why Chiral was
willing to assist the doctors, beyond the expected
role of just being a distributor, etc.. ($$$)
Stroke & MS were last listed without any Phase assignment.
Now both are Phase 2. That is absolutely outstanding.
Shows FDA now believes in safety and all future indications
should be skipping the dreaded early R&D costs, etc...
Outstanding.
1 Dr. Agresti patient 50 days hospital, organ damages & dialysis.
Days later @ home & no dialysis.
FDA eIND-OLE approval time 6-8 hours.
Janet Flisak is listed as Head of Clinical Operations on NP's screenshot.
LinkedIn says 1 year
She comes from PRA Health Sciences
" About us
We are a full service global contract research organization providing a broad range of product development and data solution services to pharmaceutical and biotechnology companies around the world. Our global operations span more than 90 offices across North America, Europe, Asia, Latin America, South Africa, Australia, and the Middle East. PRA’s 17,000+ employees have participated in more than 3,800 clinical trials and have supported pivotal trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 85 products since 2000". 10,001+ employees
From her CytoDyn LinkedIn profile:
Director, Clinical Program Lead
Janssen Inc.
2006 - 20159 years
Spring House, Pennsylvania
People and Trial Management - Oncology, small and large molecule
Janssen Inc is also a J&J company.
Her second LinkedIn profile still lists her as a Director @ J&J.
She's pulling double duty. : ))
Maybe a possible J&J vaccine with Leronlimab. (??)
49 min: Have also shipped Leronlimab to UK, Ireland.
" already shipped quite a bit of product to Italy, for the clinical trial
we conducted there"
Anyone who said Philippine is a nothing issue, is wrong.
Their new case projection is 100k.
News & Chiral said couple years for vaccine.
Their 2021 covid budget is $3.5b and it is a cash budget.
They plan to apply for World Bank & IMF vaccine $$.
The FDA is moving at lighting speed on eIND-OLE's and no reason
to think they will not be doing the same on 394 MR's.
The unannounced shipments and Italy trials, shows this will surprise
with multiple dealings that were all pre-FDA approval.
One other sign to that, of a lot of backroom activity -- notice trial data comments
from Nader, was known, since Jan. 7th. It's titled Board Meeting.
Date of screenshot he put up, when answering a question.
So add an additional month of trial data, etc.. for consideration to the FDA.
