Rivulet Media Inc (fka RIVU)

[PeterGates]

Again asking for FDA receipt Date for IND is not asking inside informaton. I have sent over 20 emails over last two months and NOT A SINGLE REPLY FROM CEO??? How can you justify that action???

Read this also: This is from FDA.


Dear Peter,

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER).

Please note that the FDA is only able to provide information on approved drug product applications. Any information on an application that has yet to receive an approval or was denied approval belongs to the manufacturer/sponsor developing the drug (21 CFR 314.430). Therefore, this proprietary information, including IND application information, is not releasable from the FDA. We encourage you to contact the sponsor directly to inquire about products under development.

Information on specific approved NDAs or ANDAs may be found on Drugs@FDA at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

Best regards,

B.C.
Drug Information Specialist | Division of Drug Information
Center for Drug Evaluation and Research | Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.




From: Peter Gates [mailto:[e-mail]]
Sent: Wednesday, March 20, 2013 11:16 AM
To: CDER DRUG INFO
Subject: Request: Status of IND number 15376

Hello,

Can you please provide the status of IND number 15376 for its proposed Phase I/II clinical trial evaluating use of its stem cell product, HemaXellerate, for treatment of aplastic anemia? Is it on Hold? What are the area(s) of clarification needed?

Thanks in advance.

Peter