Thanks, NLNK 2014 Jan options volume and premium is telling
me something is cooking behind the door and expecting some
news to come before Jan 18th. May be wallstreet finally come
around to CEO's view the delay is the result of treatment arm
patients living longer and 1st look has a very good chance to
stop the trials. Any way, there are thousands Jan options in
the money and more are bought today, some funds want to call
the stock and get ready, IMO.
Another hints were CEO refusing to say when the interrim and final events
happened, to me he was "lying" when said he did not know, he not only
knew the timing, he may even has very good idea the OS results, and that
is why he does not want to provide the timing of the final event so we can
not model the OS results predicting failure. VICL did the same thing.
Someone bought a bull Jan spread, bought 1500 Jan 30 calls for 1.5 and sold Jan 40 for
50 cents, cost $150K. I can only think two things to make money on the trade, partnership
for rest of world or 1st look results leaked, IMO.
By the way, shorts should think twice, CMG missed earnings and
stock jumped 70 next day, one product, too expensive compare to
competitor's, valuation too high...does not matter to CMG any way!
Market is expecting DECK to grow earnings 9.4% for next 5 years
and LULU to grow earnings 18.9%, double of DECK's rate, so
LULU should be 2 X DECK's Forward P/E 18.3 = 36.6, LULU
stock should be $2.5 X 36.6 = 91.5 fair price, 80 is possible
tomorrow if LULU report 44+ cents, IMO.
You mean like DECK's earnings report on OCT 25, I am betting LULU
to beat the estimates, worst case 68 to 70 like PVH or COST with so-so
earnings report, more likely DECK or GIII reactions. LULU should be trading
with AU valuation. Wellington Management Company bought 8.7M shares
in Q3, that should tell me something about Q3 earnings, IMO.
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.