02 09 CC Rough notes COVID-19 - Teleconfere

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