Ann: Becoming a substantial holder, page-10

Pigs making up FDA policy on the fly again. As discussed at least twice previously, please see the FDA comments below. Furthermore, feel free to find an FDA guidance document that confirms your claim orphan drugs have much lower regulatory standards than other drugs..

"We've been through this before. Never let FDA policies get in the way of your agenda hey?

https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products

"The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.""