Good Morning Cellceutix Shareholders and watchers
Post# of 72446
Posted On: 05/30/2013 8:52:23 AM
Good Morning Cellceutix Shareholders and watchers 
I think we should all take a moment to take a deep breath and get a bit of perspective on ASCO. A pretty smart poster here made the good point that ASCO should not be seen as some sort of binary event for CTIX, given all the anticipation surrounding P21 results and possible trial details being released.
So while I am very excited and very much looking forward to see what comes out of ASCO (and even more so POST-ASCO), I am not losing sight of the possibility that we may not get any "new" significant trial news coming out of ASCO and the accompanying company PR that is supposedly coming.
Remember, the most important thing right now for the Kevetrin DF trial is that the PK/PD data looks good and the drug is safely being administered in humans.
Safety, safety, safety is the key. Not efficacy at this point.
Now don't get me wrong, you have read my write ups/posts and know I am as optimistic as anyone on the prospects of K in this trial. However, the reality is that we here have set the bar so high in our minds for what "good" news is (and I am guilty of this myself), we need to keep perspective. Even if nothing regarding P21 is announced yet, as long as the drug is being well tolerated to this point, then everything is on track with the trial and the magic E word can come into play at higher doses at a later time.
Don't forget, Dr. Shapiro will presumably have data from just the first 3 cohorts at his disposal: 10mg/m2, 20mg/m2, 40mg/m2. Not exactly earth shattering high doses, so a lack of P21 news from these low doses should not be seen as some "bad" news, just expected "non" news. These are light doses.
Of course, the whole point of testing the P21 biomarker is to investigate for anti tumor activity early on in the trial, and if we do happen to see a difference in expression then that is IMO an early "home run" as Leo put it before. But the most likely scenario is that this may not be the case, and we as investors should be prepared for this "non" news as much as "good" news.
Just my humble opinion of course. Having said all that, I am still quite excited and believe that we get to hear what we've all been waiting for. But at the same time I am trying to temper my enthusiasm. I will also gladly take a simple and less sexy announcement along the lines of "safety is good so far".
DF is laying the groundwork for all other future trials and testing, so as long as we establish a good safety profile and MTD, this trial should be considered a success, P21 and efficacy speculation aside.
Again, just my opinion, just trying to "check myself" as I know many of us are very much looking forward to seeing what comes out of ASCO.
I think we should all take a moment to take a deep breath and get a bit of perspective on ASCO. A pretty smart poster here made the good point that ASCO should not be seen as some sort of binary event for CTIX, given all the anticipation surrounding P21 results and possible trial details being released.
So while I am very excited and very much looking forward to see what comes out of ASCO (and even more so POST-ASCO), I am not losing sight of the possibility that we may not get any "new" significant trial news coming out of ASCO and the accompanying company PR that is supposedly coming.
Remember, the most important thing right now for the Kevetrin DF trial is that the PK/PD data looks good and the drug is safely being administered in humans.
Safety, safety, safety is the key. Not efficacy at this point.
Now don't get me wrong, you have read my write ups/posts and know I am as optimistic as anyone on the prospects of K in this trial. However, the reality is that we here have set the bar so high in our minds for what "good" news is (and I am guilty of this myself), we need to keep perspective. Even if nothing regarding P21 is announced yet, as long as the drug is being well tolerated to this point, then everything is on track with the trial and the magic E word can come into play at higher doses at a later time.
Don't forget, Dr. Shapiro will presumably have data from just the first 3 cohorts at his disposal: 10mg/m2, 20mg/m2, 40mg/m2. Not exactly earth shattering high doses, so a lack of P21 news from these low doses should not be seen as some "bad" news, just expected "non" news. These are light doses.
Of course, the whole point of testing the P21 biomarker is to investigate for anti tumor activity early on in the trial, and if we do happen to see a difference in expression then that is IMO an early "home run" as Leo put it before. But the most likely scenario is that this may not be the case, and we as investors should be prepared for this "non" news as much as "good" news.
Just my humble opinion of course. Having said all that, I am still quite excited and believe that we get to hear what we've all been waiting for. But at the same time I am trying to temper my enthusiasm. I will also gladly take a simple and less sexy announcement along the lines of "safety is good so far".
DF is laying the groundwork for all other future trials and testing, so as long as we establish a good safety profile and MTD, this trial should be considered a success, P21 and efficacy speculation aside.
Again, just my opinion, just trying to "check myself" as I know many of us are very much looking forward to seeing what comes out of ASCO.
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