Tuesday, January 27, 2015 9:39:22 AM
“Would it not be a better idea to concentrate on Prurisol and Brilacidin? Get past phase 3 on at least one of these before wandering off the reservation on the Ulcerative Proctitis nonsense.
A defensin mimetic for inflammatory bowel disease, which is not an infectious process, makes no sense and will not fly. This is a waste of time,
A lot of people are getting fed up with this company and fast!”
REPLY:
Hi Tom,
I would disagree. There are always time lags in trials especially between phases. Take Prurisol as an example. We completed the crossover study. We need to wait for the lab results. OK, we were successful. Now the data has to be compiled, a briefing book prepared, etc. You then have a successful meeting with the FDA whereby they allow the Phase 2. Okay, you now call your manufacturer and place a order 2to source and manufacture your drug under cGMP conditions. That takes time. Now the FDA has authorized 4 arms with dosing of 2 pills taken twice a day.
So we now need to blister pack per cGMP each arm under instructions and coding from the statistician as it is blinded.
Arm 1 -no active in either AM or PM
Arm 2- 1 active in AM- No active in PM
Arm 3- 1 active AM- 1 active PM
Arm 4- 2 active AM- 2 active PM
Active means Prurisol
This takes time.
After delivery of the drug to sites, there is a lag time as well. Unfortunately no one has figured out a shortcut to this. We must therefore follow the rules meticulously.
We have excellent and exceptional technology in our compounds. For us to not run multiple programs would be not the right strategy. The potential GI market is likely to be significantly greater for CTIX then anti-biotics and we feel very confident with our product. During these months much research has gone into this. We very much want to enter the GI market.
Best wishes,
Leo Ehrlich | CEO |
cellceutix
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