Tyme Technologies Inc. (TYME)

[mcsharkey]

Spoiler Alert! Positive view on the COVID PROOF OF CONCEPT exercise announced last Wednesday. Probably need a PR in-order to be considered for inclusion at a shindig FDA announced on Friday:For Immediate Release: August 28, 2020
The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.

“The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to address the general development of COVID-19 vaccines on October 22nd. The agency is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” said FDA Commissioner Stephen M. Hahn, M.D. “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible.......and the [url]
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccines[/url][tag]<LINK[/tag]Got an excerpt down below from FDA's Guidance to pharmaceutical manufacturers in a downloadable file:

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry
• In instances where there is some but limited information supporting the potential for efficacy,20 approaches where an initial assessment of potential benefit can be made before enrolling a large number of subjects are appropriate. These approaches may include the following:

Conducting an initial small, controlled trial to assess for drug activity (proof-of-concept) that suggests the potential for clinical benefit.

Conducting a trial that incorporates prospectively planned criteria to stop the trial for
futility (i.e., with the prospect of expanding from a proof-of-concept phase to a larger confirmatory trial). Such a trial might also incorporate additional prospectively planned adaptations (see additional comments on adaptive design proposals below).

• FDA encourages sponsors to use an independent data monitoring committee (DMC) to ensure subject safety and trial integrity.
.....– Sponsors should submit the DMC charter as early as possible.

.....– Sponsors should ensure there will be appropriate DMC monitoring to safeguard the welfare of subjects, accounting for important factors such as the expected enrollment rate, the expected lag time to analyze interim data for DMC meetings, and the frequency of DMC meetings.

.....– If enrollment is anticipated to be rapid, but additional safety data are needed before dosing a large number of subjects, an enrollment pause could be built into the trial. In this case, enrollment would be temporarily halted, and the DMC would assess the data and then recommend that the trial or dosing group either terminate or resume enrollment.

And the:<LINK>r;

I do believe this is a real opportunity. Haven't found Emergency Use Authorization monitoring pages with new submittals yet. Back in April, I did use it for Test Kits on a Long Island firm I have interest in.

Looking for the current EUA page for vaccines. At this time, we wouldn't be on it anyway. Got to get the POC (Proof Of Concept) submitted.

Hopeful, AND, we gotta deal with the farthing shorts.

GLTA