Rivulet Media Inc (fka RIVU)

[relyts]

I don't think you even understand the process. The IND application is an application to be approved for clinical trials. All of these passages are in regards to the IND application and imply approval after 30 days. They don't need to actually say "We approve the application after 30 days." The fact they say "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." implies studies may begin unless there is word otherwise after 30 days therefore indicating approval.

"Upon receipt of the IND by FDA, an IND number will be assigned, and the application will be forwarded to the appropriate reviewing division. The reviewing division will send a letter to the Sponsor-Investigator providing notification of the IND number assigned, date of receipt of the original application, address where future submissions to the IND should be sent, and the name and telephone number of the FDA person to whom questions about the application should be directed. Studies shall not be initiated until 30 days after the date of receipt of the IND by FDA unless you receive earlier notification by FDA that studies may begin."

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/ucm071098.htm

Once again implying that clinical studies may begin after 30 days unless they receive notice otherwise.

And if that doesn't float your boat, here is another.

"(c)Opportunity for sponsor response. (1) If FDA proposes to terminate an IND, FDA will notify the sponsor in writing, and invite correction or explanation within a period of 30 days."

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312&showFR=1

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.

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