Dozen reasons to expected positive Ph 3 Pali results
ACTUALLY WE HAVE AT LEAST A DOZEN ANSWERS WHY TO BE POSITIVE ON THIS PHASE # PICASSO PALI TRIAl....
1) We know the trial could have achieved approvable endpoints last yr.
2) We know a trial that only needs 3 months PFS benefit was extended 3 months from expected Q4 data..
3) We know the control arm drug dox is actually in BOTH arms including Palifosfamide + dox.
4) We know the extension was not due to the timing of patient enrollment as that did not change from the previous interim review by the independent Data Monitoring Committee which said it could halt Q4
5) We know what dox can and can't do and if you do enough due diligence you can get a very good hint that the extension is not likely due to the control arm drug outperforming what it ever has done before in its history in this population.
6) We know based on a Journal of Clinical Oncology Canadian study that Dox does not work as well in patients over 60 yrs of age.
7) We know the median age of the IFOS trial that everyone is taking dox numbers from was 49 yrs old..
8) We know that the Picasso 3 Palifosfamide trial has a good number of patients over 60, a patient population results show where dox (control arm) does not work as well.
9) We know that one thing Dr J Lewis is is a brilliant, brilliant oncologist.
10) We know the quality of this trial's steering committee - top tier.
11) We know with IFOS you have to also take Mesna for renal/other side effects - with Pali you don't - so even similar efficacy with less drop outs and side effects would seem enough but it appears we have much more.
12) We know that the Picasso 3 trial COULD HAVE stopped for futility - but didn't despite multiple interim reviews by the independent data monitoring committee. We know there is efficacy. And we know the trial COULD NOT in its protocol stop for great efficacy until the predetermined number of progression events hit, which just happened. This is very important.
IF I WAS SHORT I WOULD BE GETTING VERY NERVOUS ABOUT NOW. There is a huge percentage of the float shorted and you gotta believe RJ Kirk and Fidelity (followed Kirk's lead before) will move their shares to non-borrowable when data comes out - similar pattern in previous companies like clinical data and new river. I know a number of people who will be doing the same.
Rob, realistically speaking (percentage wise), how confident are you in positive results at the end of March? If you say anything less than say 95% could you please indicate what would be the largest risk factors that you see.
I am also curious if you with your extremely large long position if you have any protective puts in place. It is always great to hear your thoughtful analysis and while many people look to you as the voice of reason for the longs on this board I think you lose some credibility by being dismissive of the risk factors involved.
I have both puts and calls and am looking for a major movement either way, so I am not trying to pump or bash, just trying to say that you should feel like you have some obligation to the rest of the longs given the amount that you write on here and the weight your words carry. Not trying to pick a fight, just saying if this was a slam dunk, why isnt the company already bought, partners announced PPS over $15? The answer is because there is a tremendous amount of risk involved. Or am I wrong? (It would not be the first time).
I do not put percentages on it - I am HIGHLY confident after doing extensive due diligence. Big Pharma's almost always wait for data - rather pay an extra $100 million up front after good data than risk their careers. The stock is lept down artificially imo because of the 8 million warrants that lallow riskless shorting with a $4.02 cover by warrant coversion - but as stock rises the warrant shorts may think twice . There is not tremendous risk imo - some but not tremndous - not with the factors I laid out - and because of this short interest and warrants and the fact that our largest shareholder Kirk has been restricted for a yr to buy imo - and he would buy a ton if stock got hit - the temporary downside would not be pretty but it wouldnt last imo - Kirk, shorts, longs like me and one big short seller would buy over 20 million shares on a big hit - and then you have the world changing IL-12 tech coming - - its why no I do not have long protective puts - because people who are scared because of lack of due diligence and ONTY and CLSN (which are meaningless to ZIOP) and that ridiculous mkt cap analysis - well they drove put premiums too high - so at 4 to me you dont buy 2 and 3 dollar puts, you sell them and take the fear premium. Thats what I did.
Listen - why isnt price $15? --- well thats a little high - but the reason its not higher - like many small biotechs before data that double or triple overnight - is fear, lack of detailed due diligence, overshorting here magnified by warrant shorting that is riskless - and the delay - which clearly to me is a positive - actually made many throw in towel not willing to wait another 3 months for data with other bios moving. Thats a big mistake. As I said at $4 - ZIOP is and still is my top pick for 2013....I have owned plenty of stocks the past 12 months that were destroyed and too low that came alive on news, partnerships, data - including ACAD, ECYT, MITI, SRPT, HGSI - all of their message boards had similar posts about if data is good or partnership is coming why is stock not higher - and then when the data or deal came - the stocks absolutely soared,