Has been a long week and I am finally getting to digest the conference call on 09/02. No tea leaf reading required...MHRA favors Leronlimab and is expediting regulatory process to get this to their people. See conference note below on COVID/HIV:
Nader thanks shareholders for grassroots awareness
September 9th – Granted meeting teleconference with MHRA to discuss Fast Track Approval on 09/09
• August 14th – Cytodyn requests Fast Track Approval to MHRA due to CD10 topline report; EIND data; other data
• August 24th – MHRA responds to company that they are submitting request to senior management team in licensing division for further input
• August 27th – MHRA responds to request; teleconference to discuss the regulatory pathway for fast track approval for Leronlimab based on CD10 results; 1 hr teleconference to discuss the route to market for Leronlimab in UK; prior to this meeting MHRA needs summary of BLA and this meeting is equivalent to pre-BLA meeting in US. MHRA is requiring 5 business days to expedite review of the package – specifically Manufacturing, clinical and non-clinical. Amarex has finalized this package earlier today (09/02). Cytodyn will review this package and return to Amarex within 24 hrs (09/03). Package to be delivered on (09/04) thus meeting on (09/09). MHRA quickly granted meeting to Cytodyn on 09/09 upon hearing that company would submit package on (09/05).
August 12th – filed EUA w/FDA
• FDA has indicated that a decision is forthcoming
CD12 trial (Severe/Critical COVID19)
• UK ethical committee approved enrollment in CD12 study in UK
• Recommend Cytodyn resubmit CD12 trial to Urgent Public Health (UPH). If UPH deems CD12 trial urgent health issue, Cytodyn would receive extra support from enrollment site and from government.
• In US – interim results with be analyzed early part of October and will be shared with UK as well as US
FDA Type A meeting for combination HIV BLA
• FDA responds to company in writing yesterday (09/01) 3 days early and offered teleconference to ensure that your revised BLA meets our recommendations followed by 30-day review of new package.
Submitting 350 mg dose for combo HIV to UK and requesting monotherapy approval (700 mg) in UK
Nader thanks shareholders for grassroots awareness
September 9th – Granted meeting teleconference with MHRA to discuss Fast Track Approval on 09/09
• August 14th – Cytodyn requests Fast Track Approval to MHRA due to CD10 topline report; EIND data; other data
• August 24th – MHRA responds to company that they are submitting request to senior management team in licensing division for further input
• August 27th – MHRA responds to request; teleconference to discuss the regulatory pathway for fast track approval for Leronlimab based on CD10 results; 1 hr teleconference to discuss the route to market for Leronlimab in UK; prior to this meeting MHRA needs summary of BLA and this meeting is equivalent to pre-BLA meeting in US. MHRA is requiring 5 business days to expedite review of the package – specifically Manufacturing, clinical and non-clinical. Amarex has finalized this package earlier today (09/02). Cytodyn will review this package and return to Amarex within 24 hrs (09/03). Package to be delivered on (09/04) thus meeting on (09/09). MHRA quickly granted meeting to Cytodyn on 09/09 upon hearing that company would submit package on (09/05).
August 12th – filed EUA w/FDA
• FDA has indicated that a decision is forthcoming
CD12 trial (Severe/Critical COVID19)
• UK ethical committee approved enrollment in CD12 study in UK
• Recommend Cytodyn resubmit CD12 trial to Urgent Public Health (UPH). If UPH deems CD12 trial urgent health issue, Cytodyn would receive extra support from enrollment site and from government.
• In US – interim results with be analyzed early part of October and will be shared with UK as well as US
FDA Type A meeting for combination HIV BLA
• FDA responds to company in writing yesterday (09/01) 3 days early and offered teleconference to ensure that your revised BLA meets our recommendations followed by 30-day review of new package.
Submitting 350 mg dose for combo HIV to UK and requesting monotherapy approval (700 mg) in UK
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