Replies to post #57746 on Cannabis Science Inc (fka CBIS)

[greens12]

By the time CBIS is in Phase 1 a big Pharma partner will come in and handle most of the expenses and Guide them through the trials.
Just like GW pharma hooked up with partner Osuka for Sativex...

CBIS will follow the same path as GW or just get bought out for a higher price ..

[ahhhhhh]

I think most here know the process and the time it takes for something this important. Going by your route and order of events, how long could it take for them to get the animal safety and efficacy trials, and how long after that to get to phase 1 trials? Because even if it's not approved for a couple of years, all these thing will lead to a major build up of the PPS.

[bab1]

Doesn't the FDA allow a "Fast Track" sometimes? What is the procedure with that?

[Seshet]

You need to do your DD! FDA has evolved.

Per FDA Site

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122932.htm?utm_source=fdaSearch&utm_medium=website&utm_term=fast%20track&utm_content=4

FDA Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met. This report illustrates CBER's performance in reviewing and deciding on these requests.

Details on the FDA fast track program, including Section 112 of FDAMA and the proposed and final rules in the Federal Register can be found in the Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 11/18/98; Appendix 2; Appendix 3 - (CDER MAPP 6020.3); CBER SOPP 8405; Appendix 4.