Interesting 10K EUA THOUGHTS; From page 26 we fin

Interesting 10K EUA THOUGHTS;
From page 26 we find

We may seek an Emergency Use Authorization, or EUA, from
the FDA or similar authorization from regulatory authorities outside of the United States, such as conditional marketing authorization from the EMA.
(European Medicines Agency. https://www.ema.europa.eu/en)

If we apply for an EUA and it is granted, an EUA will authorize us to market and sell our COVID-19 treatment under certain conditions of authorization as long as the public health emergency exists.

The FDA expects that companies which receive an EUA for COVID-19 treatments will proceed to licensure of their products under a full New Drug Application (NDA).

The FDA may issue an EUA during a Public Health Emergency if the agency determines that the potential benefits of a product outweigh the potential risks and if other regulatory criteria are met.

There is no guarantee that we will apply for an EUA or other similar authorization or, if we do apply, that we will be able to obtain such authorization.

If an EUA or other authorization is granted, we will rely on the FDA or other applicable regulatory authority policies and guidance governing treatments authorized in this manner in connection with the marketing and sale of our product.

If these policies and guidance change unexpectedly and/or materially or if we misinterpret them, potential sales of our product could be adversely impacted. ( commentary(C): Mr Ehrlich will likely be very cautious here.)

( C: a variable to be considered before application for a EUA )

An EUA authorizing the marketing and sale of our product will terminate upon expiration of the Public Health Emergency, which is a determination made by the Secretary of Health and Human Services.
( C: COVID-19 not very likely to go away, nor any of the other viruses which Brilacidin will target)

The FDA may also terminate an EUA if safety issues or other concerns about our product arise or if we fail to comply with the conditions of authorization.
(C: SAFETY factor makes BRILACIDIN SI *426* , so not much to be concerned about here )

If we apply for an EUA or similar authorization from regulatory authorities outside of the United States, the failure to obtain such authorization or the termination of such an authorization, if obtained, would adversely impact our ability to market and sell our COVID-19 treatment, which could adversely impact our business, financial condition and results of operations.
(C: here is where a partnership with company like Gilead would really come to play virtually ending the possible problem.)

Ronald A Phillips