Approval imo is not out of the question. �

Approval imo is not out of the question.


“See below article on all the types of regulatory pathways. LL if not EUA path may go for accelerated approval under CTAP program. It appears that once given EUA it could be difficult to get regular approval (we so want LL to be the cure for Covid and not just uaes for emergencies): “EUAs typically are not authorized with significant clinical data or assurances as to their safety or efficacy, and it can be difficult to convert an EUA to a full approval, as use of a product under an EUA doesn’t lend itself to collecting the type of clinical evidence needed to support full approval. Very few drugs or biological products qualify for this authorization pathway, though it is used extensively for medical devices and diagnostics, which generally present less risk to a patient. A sponsor is under no obligation to sell the product authorized for use, and the FDA is not able to compel them to do so.” “ Pathways specific to COVID-19 Coronavirus Treatment Acceleration Program What it is: A “special emergency program” intended to accelerate the review of therapies intended to treat, cure or prevent COVID-19. The review program “uses every available method to move new treatments to patients as quickly as possible.” The pathway combines many elements from other review programs and pathways listed below, such as rolling review, accelerated timelines, hands-on support from FDA review staff and more.” https://agencyiq.com/the-twenty-two-regulator...-patients/ “