I think the FDA will give the go ahead for a new trial based on the info they have discovered since the last one.
Remember there is no real solution for ARDs and the only thing those poor people who have it is given corto steriods which Faron believe doesn't do much for them and counteracts the effectiveness of Traukamine.
As for a partner paying for further trials... Our CEO has stated that he intends to a partner to fund the trail...
Worth remembering from some interviews from early this year he said that interested party's were interested to be contacted once they find out what the issue was..
Wouldn't suprise me if we get a RNS very soon with news on fast track Traukamine trail and how it will be paid for by a partner
Worth understanding the language of the RNS11 Dec 2019 08:18
(NK cells are best known for killing virally infected cells, and detecting and controlling early signs of cancer)
(CD8+ T-cell or killer T cell) is a T lymphocyte (a type of white blood cell) that kills cancer cells, cells that are infected (particularly with viruses), or cells that are damaged in other ways)
(CD4+ cells, are a type of T cell that play an important role in the immune system, particularly in the adaptive immune system. They help the activity of other immune cells by releasing T cell cytokines. These cells help suppress or regulate immune responses.)
(Regulatory T (Treg) cells are found at elevated densities in many human cancers and are thought to be a major barrier to the generation of robust antitumor T cell responses)
"MATINS data suggests there may be an increased value to a Clevegen partnership with a wider number of partners. As announced on 1 November 2019, the Company is working hard to optimise the structure to capture the most value from any potential deal with the best possible partner"
"With the US IND now approved, in due course, we plan to file applications for Breakthrough status in the US and Prime status in Europe, further facilitating regulatory interactions during the development of Clevegen."
Google breakthough status;
"The FDA designed its Breakthrough Therapy status to give drugs intended to treat serious conditions a head start when they demonstrate a “substantial improvement” over medical solutions already available on the market"
RE: Another giant step to curing cancer11 Dec 2019 08:02
The present finding potentially provides a method for choosing the best combination agent(s) to initiate treatment together with anti-Clever-1 therapy after observed changes in one or more checkpoint or activation marker expression.
"The Company has filed a related patent to protect this method"
RE: Another giant step to curing cancer11 Dec 2019 07:54
We intend to carry out further analysis of other MATINS patients and aim to understand which combination of IO therapies would build the optimal host immune activation for various cancer types or individuals.
To have one single and safe treatment as early as possible would improve patient outcome
"The Company is exploring various options for future API manufacturing. This termination has no impact on the currently on-going clinical advice process with FDA/EMA, which focuses on the structure of the next Traumakine clinical study"
And then this:
"The Company will have a face-to-face meeting with the FDA in early December 2019, which is expected to result in a written opinion of the FDA on the Company's clinical development plan for Traumakine"
"The Company currently envisages that a further Traumakine trial is likely to be funded through third party funding"