Cytodyn Inc (CYDY)

[bluefish1]

There's no documentation available to look at. For your reading pleasure...

No documentation does not equal no application. It isn't just what Nader said. It's the fact that when he says it, he speaks for the company. That's the law. If he says it, and he's making it up, that's a violation. He subjects himself and the company to fines and penalties. Not happening. Myth busted. FDA would have already taken action at this point.

Requirements Applicable to Drugs and Biologics in the United States

In the United States, the Food and Drug Administration (FDA) regulates drugs and biologics under the Federal Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), and implementing regulations. Section 505 of the FDCA prohibits the introduction of a new drug into interstate commerce without an FDA approved application for marketing authorization under either section 505(b) or section 505(j). Applications under FDCA section 505 include the new drug application (NDA), the abbreviated new drug application (ANDA) and the “505(b)(2)” application. Section 351 of the PHSA imposes a similar requirement for biological products. Applications under PHSA section 351 include the biologics license application (BLA) and the biosimilar application.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the development process, approval process, or after approval may subject a company to significant sanctions, including refusal to approve pending applications, withdrawal of an approval, clinical holds, warning letters, product recalls, product seizures, injunctions, fines, refusals of government contracts, restitution, disgorgement, or other civil or criminal penalties.