Intellipharmaceutics International Inc. (IPCI)

[doogdilinger]

In the past I would totally agree that IPCI should prepare for the FDA to comeback after IPCI submits bioequivalence and inform them that they still have to do phase III trials.

But given all the recent push within congress and the FDA to speed up drug approvals...the 2 recent FDA decisions pertaining to IPCI's Rexista progress make all the more sense ie: FDA granting IPCI a fast track designation and the FDA advising IPCI that they're so impressed with IPCI's phase 1 trial results that they can skip phase III entirely.

2 paragraphs from earlier this month which totally fit into the FDA's 2 recent decisions on IPCI's Rexista pathway to approval>>>

The legislation contains numerous ways for FDA regulators to accelerate clinical trials of products, including allowing the use of data from case studies, patients' experiences, other countries and medical journals

Other provisions would speed how many drugs and devices reach consumers, such as letting regulators approve some medical equipment with shorter studies using fewer people. New uses of existing drugs could be based partly on case studies and other processes that are less rigorous than traditional clinical trials.