Nader seemed different tonight, confused, babbling
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(Total Views: 742)
Posted On: 03/06/2021 11:59:01 PM
Re: ClosetInvestor #81511
Nader seemed different tonight, confused, babbling, maybe anxious, maybe frustrated but trying to maintain optimism. Dr Been: "ok, got it, let's move on"
US FDA wants another trial with 140 more critical patients from the trial sites.
Not great news. Waiting..There is some thought that this is to support full FDA approval and/or that it is because Nader wants a full approval.
Janet Woodcock "could/should/might" give an EUA for s/c and m/m based upon old & new eIND data, OLE data, m/m trial data and s/c trial data? (Stat Sig not needed?)
May Be Effective and Is Safe?
Longhauler market is huge, Leronlimab should play a major role.
The Philippians could order leronlimab at any time.
Europe is allowing Cytodyn to add data from 46 additional open label cases
Pretty good news. Great news if it results in purchases of leronlimab, soon.
Canada will allow sales while enrolling additional patients.
Pretty good news. Great news if it happens soon.
US FDA wants another trial with 140 more critical patients from the trial sites.
Not great news. Waiting..There is some thought that this is to support full FDA approval and/or that it is because Nader wants a full approval.
Janet Woodcock "could/should/might" give an EUA for s/c and m/m based upon old & new eIND data, OLE data, m/m trial data and s/c trial data? (Stat Sig not needed?)
May Be Effective and Is Safe?
Longhauler market is huge, Leronlimab should play a major role.
The Philippians could order leronlimab at any time.
Europe is allowing Cytodyn to add data from 46 additional open label cases
Pretty good news. Great news if it results in purchases of leronlimab, soon.
Canada will allow sales while enrolling additional patients.
Pretty good news. Great news if it happens soon.
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