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Thursday, 01/28/2021 4:06:16 PM

Thursday, January 28, 2021 4:06:16 PM

Post# of 75

BioVaxys and FDA permits, in extraordinary circumstances FDA can approve even the unapproved or products that are not evaluated, because of dire need!...
BioVaxys seems to be spearheading for T cell diagnostic tests using their patented test tools!... unique or not, it is a necessity right now...and huge potential!!!



Covid-T™ Clinical Development Program Initiated Regulatory Advisory Group Engaged

VANCOUVER, BC, Jan. 28, 2021 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: LMNGF) ("BioVaxys" or "Company") is pleased to announce that it has initiated the clinical development program for Covid-T™, the Company's novel diagnostic platform for detecting T-cell activity. The US Food and Drug Administration ("FDA") has tentatively agreed to permit that BioVaxys can file for a pre-Emergency Use Authorization ("EUA") for Covid-T™. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

https://www.otcmarkets.com/stock/LMNGF/news/story?e&id=1795890