I think NLNK will PR the 222 event, CEO is confident the trial results
and has been very transparent with trial data release, like the enrollment
and patients' base line data, very few let individual investors know.
NLNK will PR the topline primory end point P value and MOS as soon
as few days, in case of NLNK, it is a interim look, if it is a stop, it may
take week or two before we know it because NLNK and DMC may have
to consult with FDA that may take some time, if it is a continue, we will know right after NLNK gets the DMC decision.
Here is my time line guess:
It takes normal 6 to 8 weeks to scrub and clean the data base,
if the 222th event happens by first week in Feb, NLNK will try very
hard to meet the 2014 ASCO later break abstract dead line April 1st
to present the data if it is a stop. I am 100% sure NLNK has already submit
the later break place holder in already. If NLNK has CMC in order,
the filing NDA takes 4 to 6 month and FDA approve 4 to 6 month,
which means faster approval by end of 2014, most likely 2015 Q1.
Once HyperAcute PC is approved by FDA by end of next year, I think Dr understand
this chemosensitization effect, and they will off-label use HyperAcute PC on any stage
of the PC patients they think HyperAcute PC may help, HyperAcute PC should be used
on at least half of 45K/year PC patients with $100K/year treatment cost, that is a $2+B
potential in US only. We are looking at $100K very effective new drugs every where now.
The even bigger market is the non-small cell lung cancer, the off-label use on early stage
patients will be off the charts if HyperAcute NSCLC works. If 1st look stops the trial Q1
next year, HyperAcute NSCLC results will rock in 2015 because market will see
the INF-y responders' MOS 21 month VS SOC 7.3 month may be very real.
For example, let's use acolonf5 estimate:
"My numbers have 30 vaccine vs. 20 control as of the middle of December. This would be about 162 control group deaths (around 320 enrolled as of 4/12) and 60 vaccine group deaths (around 120 enrolled as of 6/11). "
The percentage of patients alive in the drug arm is (361-60)/361 = 83.4% as compared with (361-162)/361 =
55.1% in the placebo arm at the time of the interim analysis data cut-off date, a (83.4-55.1)/55.1=51.36
Reduction in the Risk of Death, Hazard Ratio=0.4864 and p less than 0.0001?
Not exactly but close, the 50% improvements means 50% Reduction in the Risk of Death,
a HR = 0.5
We can see from MDVN interim stop PR:
"Study Will Be Stopped Early and Enzalutamide Will Be Offered to All Qualified Study Participants; 30% Reduction in the Risk of Death, Hazard Ratio=0.70 (p less than 0.0001); 81% Reduction in the Risk of Radiographic Progression or Death, Hazard Ratio=0.19 (p less than 0.0001)
The percentage of patients alive in the enzalutamide arm was 72% as compared with 65% in the placebo arm at the time of the interim analysis data cut-off date. Treatment with enzalutamide resulted in a calculated point estimate for median overall survival of 32.4 months (95% confidence interval, 31.5 months-upper limit not yet reached) versus 30.2 months (95% confidence interval, 28.0 months-upper limit not yet reached) for patients receiving placebo. Because the trial will be stopped early with the majority of patients still alive, the estimated median survivals are not as precise as the hazard ratio. The hazard ratio takes into account available information about the trial endpoint from all patients whereas the median is a single point estimate of a much smaller number of patients at risk."
I am thinking the missing comments of "we aren't convinced if its going to happen this year"
too, my reading is after late OCT event check, CEO can see clearly the timing of the 222th event,
and he may hint it at the after presentation Q&A that can happen most likely in Dec or Jan,
the stock is reacting to this information now, We may see a new coverage from Credit Suisse
or update from Stifel soon, IMO.
Let's be conservative and use CEO's # 25 MOS now which
I believe is calculated using real time events, what do you see?
I believe the 1st look efficacy is determined by HR, like MDVN's
trial I posted few weeks ago here.
and CEO Link is convinced the control arm MOS tops at 20,
that gives us a estimate drug arm MOS 30 now, a 50%
advantage, with each month increases 2 month MOS for
treated arm....if the 222th event hits in Jan, the results
is 34 VS 20 or better, 70% MOS improvement.
You have to ask why is this happening, it is a repeat of
DNDN's power play in 2004, GSK wants SRPT cheap
and FDA play along, IMO.
Now in a sad way for SRPT share holders, it is in the best interest
of DMD for SRPT to sell to GSK and get the best price possible, my
guess is 45 and the deal gets done before the PIII starts, so may be
before Mar 2014, IMO.
We may not see much down side here around $17, but
once the 222th event is confirmed, I expect NLNK will
start to trade up to 27 to 30, and open at 60+ if stop
for efficacy, My guess is NLNK may try to file later
break abstract for 2014 ASCO if 222th event hit in
Jan or 1st half Feb.
From today's SEC filing:
"The primary endpoint for our IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 trial with
algenpantucel-L for patients with surgically-resected pancreatic cancer is overall survival and, as determined by the SPA, the first interim
analysis will be conducted when 222 deaths are reported for the study. This triggering event for the first interim analysis has not yet occurred. "
Going to listen to today's Presentation too.
It shows Drisa works on many patients with the 6mg dose,
but the dose is very harmful to kidney with unacceptable % patients
and for GSK to discontinue all the trial patients, GSK most know
the long term rsik much outweight the potential penefits, there is
no way Drisa can compete with Etep, I do not why is so hard for
some people see the big picture that Drisa works helps Etep
in front FDA that SKIPPING is working as expected by Both
Drisa and Etep, but Etep is the clear winner without any doubt, IMO.