Statement: I have sold $5.00 Nov PUTS on PARD, an IV play.
The skinny: Small-Mid size Pharma, Poniard post income after the bell this day. Expect a loss. Company has cash to burn via stock trades with banks. Not posting this data as is easy to look up for yourself. The big event is FDA approval/disapproval of picoplatin, which just completed phase 3 trail Oct 15, 2009 and we await results. Remember the date OCT 15, you will need this date later in this post. Results are to be posted (this) 4th quarter of 2009. The volatility of the options has skyrocketed.
I have researched the living daylights out of this pharma trying to answer just one simple question: Did the 320 event (death) occur as originally predicted with the 14/27 time frame by CEO Jerry McMahon or was the SPEAR trail completed later than originally anticipated??????? It appears I m not the only one, many analysts, stock message boards, ask the same question about the SPEAR trial. More noted below.... . Reason?. When a Phase III trail is ongoing, if the 320 event occurs later than predicted I ASSUME the patients lived longer than expected and bias towards positive results. I never want to own stock in a pharma that has completed a phase 3 trial 320th event earlier than predicted.
The previously predicted end date of a phase 3 trial in not part of the data lock. There are a lot of factors such as late enrollment that can skew this assumption so beware if you try to make the same assumption. You can get into trouble real fast with assumptions like this. I worked in a bio lab level 3, retired now, and I can't emphathise enough there is no possible way to predict FDA decisions. However, I like to be prepared ahead of time if possible and PLAN actions on options or stocks. With those assumptions in mind, I want to make it absolutely clear I am not placing any directional stock strategies on PARD based on the info presented below.
My current position is so noted and is strictly an IV play. I do plan to listen to the conference call after the bell this day and if any mention by Poniard regarding SPEAR data is positive, that info and with the below data, then and not until then, I will make a decision on future PARD investment strategy.
I have copies of the interview(s) between McMahon and Canaccord Adams analyst(s) George Farmer Aug. 04, 2009 8:30 PM GMT. Also Merriman Curhan Ford Analyst, Mike King; Westport Capital Markets analysts, George Zavoico. The most eye catching transcript is between Zavoico and McMahon.
Zavoico to Mcmhon: "Okay, and, finally, last question regarding the 320th event- is it safe to interpret or is it correct to interpret that the longer it takes to reach the 320th event the more likely that the (inaudible) week or greater-than 27-week target is going to be reached?"
McMahon, Chairman Poniard: "What I think we can say is based upon the data that we currently have, related to the use of picoplatin and its treatment population, the confidence interval related to our Phase 2 trial ranged up to 36 weeks.
So--what that means, of course, is that we really don't know exactly what would be the range of follow-up that would lead to that data. But, obviously, not achieving the 320th event as of today, it's consistent with our data assumptions, to date. So that's all we can say at this point, but we know there's a range that's involved here. But, so far, everything that we would expect seems to be on track."
Jerry McMahon, Poniard Pharmaceuticals, Inc. Chairman and CEO On August 04, 2009 / 8:30 PM GMT Conference Call:
"We can't because I am blinded to--we are blinded to the event rate. We have an independent CRO that manages or, if you will, is the interface between the data at the sites and so, therefore, we don't have that information.
Our best assessment remains related to expected time to follow a -- following assumptions, would put that event, obviously, sometime this summer."
The 320th event occurred Sept. 15, 2009, later than last summer i.e. "sometime this summer."
Brent Holly, analyst, Oppenheimer & Co. March 16, 2009:
"Thanks for taking the question. I was just wondering if we had a little bit more of a definitive timeline on the SPEAR data? We're well into March here, it seems we're getting--we're not at the middle of the year, but just wondering is this more of a second quarter event, or is that just not possible to assess even now at this later date?
Jerry McMahon" You know, now, Brent, the original assumptions that went into this trial, as you know,assumed that the treatment arm patients live 27 weeks, and the best support of care arm patients live 14 weeks. So our ability to predict when that 320th individual or event would occur is really subject to those assumptions, and our best guess at this point, given the fact that we have very robust enrollment is that, based on those assumptions, that the middle of 2009 is our best guess for when that event would occur, and that's based upon those assumptions."
I must have 14 pages of copies of every interview I could find with McMahon. Only copied a few quotes as noted in bold. Every analysts directs the same question to McMahon i.e. is SPEAR trial 320th event taking longer than previously predicted.
I have presented the data only for your viewing pleasure. DO NOT make careless assumptions based on this message AND MAKE A DIRECTIONAL PALY OF PARD. There are a Quadrillion other facts to consider other than what is posted here.
Please don't mention to Uncle Sam the word quadrillion. Would hate for the Govt. to figure out what comes after trillion. Any positive criticism is appreciated.
Thanks to TJ and OF for the tip on PARD IV play in OCT. My trade, thanks to you two fellows is working very well at this point.
Good Trading
Montana
