The CC was much more informative than I would have thought.
First of all, I sold my entire position yesterday morning and I am glad I did(thx Wall)...I thought we had a 75% chance for approval so an approvable letter at 25% chance wouldnt have shocked me by any means but what I wasnt expecting was an approvable letter before 5/15!...in other words, didnt hedge in time...oh well.
Gold actually revealed more than I thought he was going to today.
I was just going to forget about DNDN for a long long time but Im not so sure about this anymore. Gold said a few things that made me rethink this. I will most likely buy below 4.00 now.
Here were my concerns before the CC. I pretty much figured that 9902B survival data was going to be needed before filing again(hence nothing to get excited about til 09-10'). I was concerned about the interim look of 9902B also. My concern dealt with the pt's in 9902B being sicker(ie-minimally sx-atic this time), how much alpha the co. was going to spend on the interim first look and lastly , the crossover issue.
Gold made it very clear that the demographics of the pts in 9902B were very similar to the pts in 9901...so maybe they are not that much sicker...Urdal said that survival between a-sx-atic and minimally sx-atic was similar...Gold appeared to hint that perhaps we should expect similar results?...in my mind, he also confirmed that they understood the gravity of having positive data and momentum by next yr since funds will run dry by middle of next yr imo...he verified that they will spend enough alpha to allow the interim first look to be meaningful...we can file again if the interim look is significant(as noted in the SPA)...lastly, the thing I didnt really appreciate regarding the crossover issue is this, he noted that the Provenge that the crossovers receive isnt the same as the pts in the tx arm receive and the crossover Provenge isnt as powerful...did I hear that correctly?...well, although I'm not going to rush out and buy any DNDN shares tomorrow, it does give me some hope that we can start to take a position again perhaps late this yr or early next yr if we get guidance from the company that doesnt scare us away...actually, anything in the 3.00's is fair imho.
On a side note, I felt really horrible yesterday and today cause one of my pt's with rapidly progressing prostate cancer was really hoping Provenge would get approved...he is scheduled to start Taxotere next week and he really doesnt want to secondary to the SE's. He wanted Provenge!. I felt even worse cause he told me a few days ago that he bought DNDN last week to support the company...so not only does he not get Provenge but he takes a 60% haircut...now that really pisses me off! I am going to contact Dendreon and see if he can have access to Provenge even if he has to pay for it himself...he is too advanced to be on 9902B.
I see this guy as friend and a patient and if the FDA(Hussain/Scher/Fleming/Pazdur/Witten/Goodman/Von Eschenbach) could see pt's this way instead of just a disease or a statistic, Provenge would have been approved...these MD's have lost sight of whats important...while I would agree that you cannot bring drugs to mkt with weak data packages but for end stage incurable cancers, the bar has to be set lower especially if the side effect profile is good like Provenge...if my daughter was dying from incurable cancer and there was a drug that missed the primary endpoint by 0.002(ie-0.052 vs 0.050) and there was 3-4 fold OS benefit and someone told me she couldnt have access to that drug because the primary endpoint was missed hence the OS benefit was hypothesis generating only I would punch him(maybe even a her too) in the face I kid you not...any reasonable parent would!... so would Scher and Hussain, thats the sick part of this.
Ok, Im going off on tangents so now I will stop.
AI
