Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

Sorry Noodle, Fast track designation does not eliminate any trials and tribulations required in order to file an NDA, but it does mean the FDA will work closely with IPCI and expedite any meetings and paperwork reviews required... and most of all it cuts the PDUFA date down to 6 months rather than the customary 10 months.

I'm also not sure they would not need to start with a phase 1 study, as that is the phase which primarily focuses on safety... after all IPCI claims that they can give a lethal dose of the drug without affecting the patient... you don't prove that in phase 3... you prove it, and very slowly and carefully, in phase 1 where you dose 1 person, wait to see results... dose 2 people, wait to see results... dose 4 people etc. etc... luckily, unlike cancer, we don't need to wait months or years to see results - you dose the first patient at night... and if he wakes up in the morning... you're good to go dose the next 2... LOL.