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Monday, 05/03/2021 12:46:33 AM

Monday, May 03, 2021 12:46:33 AM

Post# of 3647
Status of CVBT/VT Clinical Trials?
As an outsider it’s hard to triangulate on the true status of CVBT/VT clinical trials.
Let us turn to the tangible with CVBT/VT clinical programs. Absent any official Company news releases from CVBT/VT on the resuming of a clinical trial for coronary heart disease and/or wound healing in diabetic foot or venous stasis ulcers we have nothing but innuendo from this site. Investors Hub recent posts refer to these trials as pivotal (which are either P-2B or P-3) and according to the guidelines of clinicaltrials.gov data base, sponsors are required to update the clinical trials.gov data bases for trials at this stage of development. Some P-1 trials are still likely exempt from posting. It appears that the last clinicaltrials.gov update for all three CVBT/VT clinical programs; peripheral arterial disease (PAD), coronary artery disease (CAD) and wound healing of diabetic and venous stasis ulcers was in November of 2019.
CVBT CAD Trial:
https://clinicaltrials.gov/ct2/show/NCT00117936?term=cvbt&draw=2&rank=4

CVBT Treatment of diabetic or venous stasis ulcers:
https://clinicaltrials.gov/ct2/show/NCT00425178?term=cvbt&draw=2&rank=3

CVBT PAD Trial:
https://clinicaltrials.gov/ct2/show/NCT00424866?term=cvbt&draw=2&rank=2

The wound healing trial is reported to be complete. According to clinicaltrials.gov it was an 8-patient trial and by drug development standards would not be considered pivotal in nature. A new P2/3 wound healing protocol has not been posted to the site. If there is a P-2/3 wound healing trial ongoing in the US and not posted it would be in violation of the clinicaltrials.gov guidelines. Same is true for a P-2 trial in CAD. The US FDA in a recently issued guidance April 28, 2021 (see link below) states they intend taking action against sponsors who do not populate the clinical trials.gov site with the required information in a timely fashion.
https://www.fda.gov/news-events/press-announcements/fda-takes-action-failure-submit-required-clinical-trial-results-information-clinicaltrials.gov
If any new clinical trial(s) is/are under way under CVBT’s sponsorship, then good for CVBT/VT and its shareholders.
If not, when might they begin and what are the gating events associated with the restart?


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