I will continue to add to add to my position. A little disappointed but achieving milestones in production, distribution etc. has always surfaced as a question by myself and IMO big pharma. Proving the efficacy appears to be a done deal and now FDA approval of the production and process alluded to by Brian Thom should now provide conclusive evidence to a buyer to close or bring negotiation(s) for a buyout to fruition.

“ their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. (And prove the viability of the product to a buyer) We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”