Replies to post #38290 on Rivulet Media Inc (fka RIVU)

[stockboy281]

ok cool here is what i gathered


Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or other organizations interested in bringing a new drug to market. Each of the sections below contains information from CDER to assist you in the IND application process. For specific information, click on a link to go directly to a section or web page.

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm


I agree not to begin clinical investigations until 30 days after FDA’s receipt of the IND unless I receive earlier notification
by FDA that the studies may begin. I also agree not to begin or continue clinical investigations covered by the IND if those
studies are placed on clinical hold or financial hold. I agree that an Institutional Review Board (IRB) that complies with the
requirements set forth in 21 CFR Part 56 will be responsible for initial and continuing review and approval of each of the
studies in the proposed clinical investigation. I agree to conduct the investigation in accordance with all other applicable
regulatory requirements.

Pulled straight from the app itself

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf

Please explain how these people are wrong and you are right? We have 30 days until we can start clinical trials unless halted by the FDA correct?

[relyts]

This isn't a college essay. You're a grown man (I think) and you can decipher what has been presented to you from the FDA site itself. The fact that they imply clinical studies may begin implies approval. Do they really need to spell it out for you? You're using misdirection.