02 09 CC Rough notes COVID-19 - Teleconfere
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Posted On: 09/02/2020 4:41:24 PM
Re: ClosetInvestor #53786
02 09 CC Rough notes
COVID-19
- Teleconference meeting with UK MHRA on September 9 re: fast track approval, equivalent to pre-BLA meeting; BLA summary package to be submitted them on 04 09; encouraging previous communication with MHRA
- Regarding EUA in US: decision forthcoming
- CD-12 enrollment in UK: study is clear to go; UPHS could provide financial and clinical support for CD-12 trial
- CD-12 US: interim analysis early October
HIV BLA
- BLA submission for HIV in US: Written responses received; FDA offers to conduct a review prior to BLA submission; Type A meeting on September 8
- HIV BLA in UK: 350mg combination therapy, possibly monotherapy with 700mg
CANCER PROGRAMME
Creative Microtech guy: CCR5 one of the most expressed receptors in cancer; encouraging historical data on improved patient outcomes
- Clinical outcomes needed for approval
- SK: research into microtumour environment; exploring leronlimab's roll; complimentary treatments for leronlimab
- Business development: contact with various international pharma companies; one approval will help credibility of the company
COVID-19 longhaulers trial
- Preparing a protocol for longhaulers; after EUA patients who contacted company might be helped.
STATUS OF PUBLICATION OF MANUSCRIPT
- CD-10 trial results manuscript to be reviewed; feedback in a couple of days; other manuscripts submitted (Otto Yang); HIV prep manuscript ready in the next weeks; other HIV trials manuscripts being prepared too
UPLISTING
- Still in evaluation mode with NASDAQ; received comment letter in week 4
- Preparing responses to anticipated issues; "more variables", takes more time...
SCIENTIFIC ADVISORY BOARD
- Set up the board; more specialists/advisors to come
COVID-19
- Teleconference meeting with UK MHRA on September 9 re: fast track approval, equivalent to pre-BLA meeting; BLA summary package to be submitted them on 04 09; encouraging previous communication with MHRA
- Regarding EUA in US: decision forthcoming
- CD-12 enrollment in UK: study is clear to go; UPHS could provide financial and clinical support for CD-12 trial
- CD-12 US: interim analysis early October
HIV BLA
- BLA submission for HIV in US: Written responses received; FDA offers to conduct a review prior to BLA submission; Type A meeting on September 8
- HIV BLA in UK: 350mg combination therapy, possibly monotherapy with 700mg
CANCER PROGRAMME
Creative Microtech guy: CCR5 one of the most expressed receptors in cancer; encouraging historical data on improved patient outcomes
- Clinical outcomes needed for approval
- SK: research into microtumour environment; exploring leronlimab's roll; complimentary treatments for leronlimab
- Business development: contact with various international pharma companies; one approval will help credibility of the company
COVID-19 longhaulers trial
- Preparing a protocol for longhaulers; after EUA patients who contacted company might be helped.
STATUS OF PUBLICATION OF MANUSCRIPT
- CD-10 trial results manuscript to be reviewed; feedback in a couple of days; other manuscripts submitted (Otto Yang); HIV prep manuscript ready in the next weeks; other HIV trials manuscripts being prepared too
UPLISTING
- Still in evaluation mode with NASDAQ; received comment letter in week 4
- Preparing responses to anticipated issues; "more variables", takes more time...
SCIENTIFIC ADVISORY BOARD
- Set up the board; more specialists/advisors to come
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