Finally, on the same page. Happy Thanksgiving to you and yours. Correct. And more to be grateful for, as you and I do want this drug available to the SCD population, ASAP, pending required FEDERAL approvals.
The history of the drug (eventually being purified to MST-188) goes back decades. Due to a number of ancient issues relative to insufficient funding and insufficient data gathering practices, it could have all fallen off the proverbial map.
One man had the vision and willingness; with the applications of prior bio-science education and employment experiences, he would challenge those past odds and circumstances, to resurrect a project that was shown an impossible execution under prior attempts. One man, and one other staff member , were it, right? The past executives, scientists and any supporting staff, gone. In most circles thats called a single handed save, any thing like a Hail Mary pass? Well maybe. Anyway I am so grateful thAt he brought it to the team of 30 single focused. today.
Brian Culley has taken this from a company of two to 30 people over the years. The diagram here has been to take some prior information and a one prior drug, through a full series of trials, to full FDA approval. Fortunately the FDA appeared to desire this drug, and so awarded the EPIC trials (three phases) orphan and fast track status. Fast refers to FAST according to FDA. It takes a drug MANY years to work through the 3 phase trial and approval process. The FDA sanctioned that the validated/significant findings from prior explorations with this same drug could be used in the EPIC studies so that time would not be wasted on re dos, from what I understand. They made a few well documented recommendations to improve the studies chances and these have been well addressed.IMO. So much to bre grateful for. Best to all> All stated is IMO. DO your DD.
