Open DNA question to anyone on the board. Another COVID biotech that I track is seeking authorization to start Pre-IND trials on humans. The FDA just responded back asking them to conduct two small animal studies to prove that the drug does not impact the DNA structures. This is a new FDA concern stemming from the concerns that mRNA vaccines may impact human DNA.
Is anyone aware whether any of the RLFTF studies included assessment of impact on human DNA? It would be a shame if the FDA sprung this on RLFTF as part of the EUA application process.
Here is an excerpt of the FDA response to another biotech.....
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard.
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