Bio, it is difficult for me to understand your int
Post# of 72447
Posted On: 09/10/2013 9:56:42 PM
Bio, it is difficult for me to understand your interpretation of such substantive information to be a dog and pony show. Ctix is engaged in the most high risk of clinical endeavors, a first in kind human trial with a novel molecule. Though I have seen cohort dose projections from the boards since before the trial began,I have to say that the total milligram dose is, at this point in time, much less important than the fact that cohort evolution persists. The mg number is important mostly to people who aren't quite cognizant of how high risk and slow a trial like this is.
The information from the trial is substantive and optimal, in luding the fact that they are at 75mg. The evidence based results reported by Leo yesterday, including decrease serum tumor marker, decrease solid tumor size, continued good clearance and safety and positive p21expression - these quantifiable evidence based results are not part of a fantasy realm called koolaide. They are not composed of opinion. These results are a concrete, measurable, provable data set. They exist. For a ph1 novel molecule investor, they are outstanding.
Projected increases in cohort dose are exactly that; projections. Ph1 trials have dose titration outlines. The outlines offer an escalation framework but individual cohort members are the deciding deciding in escalation speed. (notice that i never played the 'guess the cohort dose' game? This is why. I know that to be a futile endeavor). To have cohort delays and reduction of expected next cohort titration only takes a single erythmatous response. This slow dose escalation was not unexpected. The koolaide is found in the expectations of posters who believed the titration would be smooth. It never is and slows titration is not a material event. It is an expected one.
Regarding the prurisol, Leo said he is currently completing the 502b. Communication has already taken place with the FDA. Site and site clinician team chosen and ready. No change there except in size of trial. Since they have already been told best pathway by FDA, approval of trial will not take long at all. Ic he gets app in in a couple of weeks, we'll have news of trial start in October.
I, for one, am very glad they're ditching the poc. They already have plenty of poc in their pre clinical and this is known molecule. J believe they chose poc route initially for financial reasons. With a poc, they would have early data with which to lure a partner and gain some financial investment for later trial. Now - with expansion of assets related to their recent purchase and pending uplisting, they will be in a position to allow the trial evidence for prur to be much more mature before engaging in partnership deal. This will allow them to get a mu h better deal. Far from being Kool-Aid, this is an extremely business savvy move from a seasoned financial officer. They have just dramatically increased their own profit potential from this drug. The trial is set up and the application underway. This will move fast. (typing from phone in park plaza. Please forgive typos. Spellcheck is a demon.)
The information from the trial is substantive and optimal, in luding the fact that they are at 75mg. The evidence based results reported by Leo yesterday, including decrease serum tumor marker, decrease solid tumor size, continued good clearance and safety and positive p21expression - these quantifiable evidence based results are not part of a fantasy realm called koolaide. They are not composed of opinion. These results are a concrete, measurable, provable data set. They exist. For a ph1 novel molecule investor, they are outstanding.
Projected increases in cohort dose are exactly that; projections. Ph1 trials have dose titration outlines. The outlines offer an escalation framework but individual cohort members are the deciding deciding in escalation speed. (notice that i never played the 'guess the cohort dose' game? This is why. I know that to be a futile endeavor). To have cohort delays and reduction of expected next cohort titration only takes a single erythmatous response. This slow dose escalation was not unexpected. The koolaide is found in the expectations of posters who believed the titration would be smooth. It never is and slows titration is not a material event. It is an expected one.
Regarding the prurisol, Leo said he is currently completing the 502b. Communication has already taken place with the FDA. Site and site clinician team chosen and ready. No change there except in size of trial. Since they have already been told best pathway by FDA, approval of trial will not take long at all. Ic he gets app in in a couple of weeks, we'll have news of trial start in October.
I, for one, am very glad they're ditching the poc. They already have plenty of poc in their pre clinical and this is known molecule. J believe they chose poc route initially for financial reasons. With a poc, they would have early data with which to lure a partner and gain some financial investment for later trial. Now - with expansion of assets related to their recent purchase and pending uplisting, they will be in a position to allow the trial evidence for prur to be much more mature before engaging in partnership deal. This will allow them to get a mu h better deal. Far from being Kool-Aid, this is an extremely business savvy move from a seasoned financial officer. They have just dramatically increased their own profit potential from this drug. The trial is set up and the application underway. This will move fast. (typing from phone in park plaza. Please forgive typos. Spellcheck is a demon.)
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