On two previous occasions (Jan.4th & Mar.4th) I posted messages regarding the SGN-33 double blind trial. The primary point of those messages was that the continuation of the blinded status of this SGN-33 trial was potentially good news as it possibly indicated that the required number of 186 events (deaths) had not yet occurred, and thus the trial remained in its blinded status. I commented that this time frame was well past the 5 and 1/2 month survival benchmark that had been established without the use of SGN-33, and therefore good news could be forthcoming when the trial was eventually unblinded. The 5 1/2 benchmark comment was taken from Tom Reynolds comments at the 2008 Q4 earnings call, stated as follows: "Right now, the largest study done to date was single agent low-dose ara-c shows roughly 5 1/2 months survival."
At the Cowen & Co. Healthcare Conf on 3/8/2010, Dr Clay Siegall presented a chart (Slide 15) and commented that a previous study with low dose ara-c shows a "MEDIAN" survival of 5 1/2 months. That represents a substantially different base line than was stated in the Q4 2008 earnings call, and greatly changes the significance of the fact that the SGN-33 trial previously referred to remained in a blinded status during Jan. and beyond. That in itself is not "bad" news, simply not necessarily "good" news. We'll just have to wait and see.
Since the survival chart was presented, I did take a shot at applying it to the time frames and enrollment stats as available for the ongoing SGN-33 trial. If one assumed that the 210 patients enrolled between 11/9/2007 and 2/25/09 came into the trial on a consistent time frame from the trials start to the trials closing (I'm not assuming that but using it as a benchmark) and one applied the survival rates as indicated on slide 15 of the presentation (the graph can be converted to numbers that I believe would be very close to the actual numbers behind the chart), and assumed that the addition of SGN-33 to the treatment provided no enhanced survival time frame (again, I'm not actually assuming that), the 186 event threshold would be reached during the month of March. If enrollment was more front end loaded it would not change the timing much, and if more back end loaded might move the timing closer to April. Now if we were to say that SGN-33 actually added a few months survivabilty, that would move the unblinding to April or May (keep in mind only half the patients would receive SGN-33) depending on the enrollment timing.
Previously SGEN had guided that the data would be forthcoming in the first half of this year. A couple of months ago they narrowed that time frame to Q2. Dr Siegall mentioned at the Cowen's Conf. that this Q2 guidance was an "estimate" - he mentioned it twice. Don't want to read too much into that, but possibly he is leaving open that it could slide to Q3, which from my perspective would be good news.
One last comment regarding Dr Reynolds' 5 1/2 month "survival" statement. Per the chart shown by Dr Siegall that is an accurate time frame for survival when the treatment was Hydroxyurea. Perhaps that was what Dr. Reynolds intended to refer to.
BMR, I find myself thinking quite a bit about this statement you made last week:
"Then there's the propensity for large institutional shorting weeks after an FDA approval (happens in almost all cases)."
I wonder if you would care to elaborate.
What, in your view, is generally behind this -- the usual craven and bogus activity of big players shorting after a sharp rise simply to force and profit from a pps avalanche? In your experience with this phenomenon in bio-techs, did most bio-techs eventually recover, and if so, after how long on average? Anything else you can add?
I ask because I and a few colleagues on this board were burned by that sort of thing with another "sure-shot" stock a few years ago, though it wasn't a bio-tech.
I got burned on this one:
"Trade Alert Issued for Novelos Therapeutics, Inc. (NVLT.OB) as Pivotal Phase III Drug Trial Patients Are Living Longer Than Expected."
Then on 12/24/10:
“We are very disappointed that our pivotal Phase 3 lung cancer trial did not meet the primary survival endpoint,” said Harry Palmin, President and CEO of Novelos. “We were hopeful of a positive outcome based on our statistical model simulations and stated assumptions. In retrospect, it appears our simulations were inaccurate due to trial data deviating from our statistical model, the impact of censoring patterns, and control arm survival exceeding our expectations based on historical precedents."
Quite true, biotech investors should always be very cautious about playng the "it's lasting longer than historical controls would imply, so it must be working" game.
Ask some CTIC investors from 2006 when the CEO was strongly hyping that the P3s were taking longer than expected (turned out the locations in 3rd world countries were enrolling healthier patients than per protocol).
Still, it's fun to discuss it.
We should just lable such threads "for entertainment use only" :-)
Also I believe the full potential front line revenue is closer to 1 billion - not 4 billion.
My estimate for peak SGN35 rev. in 2018 is $500 - $750 million, assuming front-line approval.
It takes $300 million in revenue to sustain a 1 billion market cap.
I'm thinking there will be quite a lag between initial approval and front-line.
Phase I front-line trial is slated to begin in May. Add to that time line phase II and III and we're looking out quite a few years.
Then there's the propensity for large institutional shorting weeks after an FDA approval (happens in almost all cases).
Still with the pipeline and collaboration $40 may be doable.
Of course I hope YOU are right.
Shorter term I Like JAZZ.
That's the basic consensus on the pipeline. ADCs are why I'm in toothand nail. Just want to add, first-line SGN-35 is touted a 4$ billion potential. $40 target is extremely conservative from that point.
Be prepared to hedge your investment for another disappointment. SGN15,30,and 40 have all been disappointments. Nothing presented thus far indicates to me 33 will be any different. Their ADC, like IMGN's TAP, is where it's at.
Hope I'm wrong. Best to expect the worst.
If this is any help to you; at the offical site for the trial design ( see link below ) the "estimated" date for final data collection for primary outcome measure is June 2010.
Estimated Enrollment: 210
Study Start Date: September 2007
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Also, I believe that the one year survival of elderly AMl patients on low dose chemo was indicated as being about 25%. Perhaps, that figure might be of interest to you in your evaluation.