Well, well, there ARE people on iFlub than can think for themselves!
Ahrdee Monday, 12/09/13 10:10:36 PM
Re: ericseb2003 post# 47985
Post # of 48030
Some of you here are so funny with the name calling and all. I point out facts based on the company's past and present official news releases and you want me to explain what their motives are. It should be enough to assess actual statements and facts to judge the veracity of claims. As for motives, one can come up with any number of speculations. This board is famous for inventing motives for anyone who expresses the slightest doubt about the infinite prospects of CTIX as a stock .
As for the Prurisol plan just announced, it does nothing to change my view about this company from what I had yesterday. I had pretty much completely discounted Prurisol potential from my valuation . The new twist is simply another turn of delay to one that has been going for a year. We have been conditioned for this in Pavlovian fashion.
Obviously, I have taken some poetic license with how the company consulted industry experts (but the caricature is probably closer to truth).
Now if we could have some honest response:
How many on this board were expecting a Phase 1 for Prurisol instead of a "Phase 2/3 under a 505(b)(2) designation"?
Here is the last PR on this. Read carefully:
Quote:
BEVERLY, MA–(Marketwired – Oct 2, 2013) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”) ... today announces that the bridging study on Prurisol, the Company’s anti-psoriasis drug candidate, has been completed by an outside vendor and that Cellceutix has received the report. The study documents the ester bond in Prurisol™ (a prodrug) is readily cleaved and converted as expected. This study was requested by the Food and Drug Administration to be included in the Investigational New Drug (“IND”) application with the FDA under a 505(b)(2) designation . This completes the lab studies needed for filing an IND for Prurisol.
Cellceutix is reviewing clinical sites in the United States and internationally to initiate a Phase 2/3 trial as Dr. Reddy’s Laboratories Ltd. finalizes the Chemistry, Manufacturing, and Controls section (“CMC”) of the IND. The CMC is expected by the end of the month and the IND filing shortly thereafter. Dr. Reddy’s has already completed the manufacturing and stability studies of Prurisol for a multi-center clinical trial.
“... The results from the final study for the FDA submission were exactly as expected. We are very eager to move Prurisol into a large-scale human trial , where we are optimistic that the drug will validate earlier research and prove itself as a new, potent therapeutic for psoriasis,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix.
All along, the talk about the FDA application for Prurisol has been for the Phase 2/3. You will not find any Phase 1 reference in regard to Prurisol in any of the past PR. The European PoC was to avoid a Phase 1; the repeated reference to 505(b)(2) path for Prurisol was about avoiding a Phase 1. It is very possible that CTIX and Dr. Menon knew that the FDA would want the ester cleavage demonstrated in animals first and then humans. If so, investors were carefully kept in the dark about it. Ultimately it is no big deal. I just don't know what to believe and what not to disbelieve in regard to the company's PR. But you are all welcome to believe that what Mssrs. Ehrlich and Menon put out are the truth, the whole truth, and nothing but the truth. What I have discovered is that that is absolutely not the case. That was a bad discovery for someone who was extremely pro this company.
So here are the possibilities in regard to the Phase 1 on Prurisol (let us forget the past PoC fantasy). Take your pick.
A. The company found at some point it will have to do a limited Phase 1, but chose not to disclose it to investors.
B. The company firmly believed it could go straight to Phase 2/3 and did not know how things work for FDA approval (and therefore we should stop making speeches about the vast industry experience of various CTIX persons).
Ahrdee Monday, 12/09/13 10:10:36 PM
Re: ericseb2003 post# 47985
Post # of 48030
Some of you here are so funny with the name calling and all. I point out facts based on the company's past and present official news releases and you want me to explain what their motives are. It should be enough to assess actual statements and facts to judge the veracity of claims. As for motives, one can come up with any number of speculations. This board is famous for inventing motives for anyone who expresses the slightest doubt about the infinite prospects of CTIX as a stock .
As for the Prurisol plan just announced, it does nothing to change my view about this company from what I had yesterday. I had pretty much completely discounted Prurisol potential from my valuation . The new twist is simply another turn of delay to one that has been going for a year. We have been conditioned for this in Pavlovian fashion.
Obviously, I have taken some poetic license with how the company consulted industry experts (but the caricature is probably closer to truth).
Now if we could have some honest response:
How many on this board were expecting a Phase 1 for Prurisol instead of a "Phase 2/3 under a 505(b)(2) designation"?
Here is the last PR on this. Read carefully:
Quote:
BEVERLY, MA–(Marketwired – Oct 2, 2013) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”) ... today announces that the bridging study on Prurisol, the Company’s anti-psoriasis drug candidate, has been completed by an outside vendor and that Cellceutix has received the report. The study documents the ester bond in Prurisol™ (a prodrug) is readily cleaved and converted as expected. This study was requested by the Food and Drug Administration to be included in the Investigational New Drug (“IND”) application with the FDA under a 505(b)(2) designation . This completes the lab studies needed for filing an IND for Prurisol.
Cellceutix is reviewing clinical sites in the United States and internationally to initiate a Phase 2/3 trial as Dr. Reddy’s Laboratories Ltd. finalizes the Chemistry, Manufacturing, and Controls section (“CMC”) of the IND. The CMC is expected by the end of the month and the IND filing shortly thereafter. Dr. Reddy’s has already completed the manufacturing and stability studies of Prurisol for a multi-center clinical trial.
“... The results from the final study for the FDA submission were exactly as expected. We are very eager to move Prurisol into a large-scale human trial , where we are optimistic that the drug will validate earlier research and prove itself as a new, potent therapeutic for psoriasis,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix.
All along, the talk about the FDA application for Prurisol has been for the Phase 2/3. You will not find any Phase 1 reference in regard to Prurisol in any of the past PR. The European PoC was to avoid a Phase 1; the repeated reference to 505(b)(2) path for Prurisol was about avoiding a Phase 1. It is very possible that CTIX and Dr. Menon knew that the FDA would want the ester cleavage demonstrated in animals first and then humans. If so, investors were carefully kept in the dark about it. Ultimately it is no big deal. I just don't know what to believe and what not to disbelieve in regard to the company's PR. But you are all welcome to believe that what Mssrs. Ehrlich and Menon put out are the truth, the whole truth, and nothing but the truth. What I have discovered is that that is absolutely not the case. That was a bad discovery for someone who was extremely pro this company.
So here are the possibilities in regard to the Phase 1 on Prurisol (let us forget the past PoC fantasy). Take your pick.
A. The company found at some point it will have to do a limited Phase 1, but chose not to disclose it to investors.
B. The company firmly believed it could go straight to Phase 2/3 and did not know how things work for FDA approval (and therefore we should stop making speeches about the vast industry experience of various CTIX persons).
