Intellipharmaceutics International Inc. (IPCI)

[Samsa]

In reply to Angelo. I can tell you why I fee he is wrong. I am not misleading anyone. the facts are all in front of you. I have said for some time that Rexista with PODRAS will require additional testing and yes is a few years away. but its still tied to the original filing. the exact tests that will be required will be determined when the company files the Supplemental. but I can guarantee you that is how this is going down. The company has not filed 2 IND's. one with and one without PODRAS. yet, the FDA has granted fast track designation for PODRAS. so your talking about two versions but one application with the FDA. If they were going to file a second application they would need two IND's. you do the math and still tell me the company will file an entirely new NDA down the road for PODRAS rather than just filing a supplemental? how can the FDA make a fast track status for an application or indication not before it? there is currently one application to be filed before FDA that they are intending to file and have had only one IND for it. yet PODRAS has received fast track status. clearly, the signs point to 1 application being filed and down the road a supplemental being applied for the include the additional indication for overdose prevention. therefore, the issue of PODRAS needs to ironed out now along with the potential partner. People are looking for some nefarious reason for the company not filing yet and it all makes perfect sense to me.