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I guess any date after July 7, abstract may be available to attendees,
so market may know too, I guess.
I agree with you, but the final may still succeed but critics may argue how useful the
treatments are, how to identify the patients who can benefit, DNDN's Provenge's story
come to mind.
Market estimates Ibrutinib peak sales about $4B, if 1101 + 1202 combo is approved
by FDA, the combo may take at least $1.5B peak sales away from Ibrutinib.
Look at PCYC stock history, PCYC traded from $12 in DEC 2012,
and $70 in July 2013 after PII results. TGTX PII results come in
Ibrutinib(+100+K/year) correction: Ibrutinib costs $100+K/year
How much is TGTX CEO Michael S. Weiss is willing to sell?
I would guess at least $1.75 to $2B before year end, or much
more if TGTX is in PIII trials next year.
If the coming up initial '1101 + '1202 combination data is as good as
the 1101+Ibrutinib(90% ORR), TGTX can price the '1101 + '1202 combination
in line with Ibrutinib(+100+K/year) and get most patients from PCYC, then
PCYC has no choice but to buy out TGTX before year end.
Here is the reason why NLNK has the first look:
You know Steve, when we look back at the phase II data, I think that what were struck by and we didn’t really fully understand, you know the phase II data didn’t have treatment arms. So the phase II data was limited. But one think that we know was true is that in the high dose group that one year out of the 26 stations, only a single patient had died and that really exceeded any expectations that experts in the field had for what would happen in terms of one year survival and that one patient when we looked at that patient had a 12 centimeter tumor, a fairly enormous tumor [indiscernible] surgery perspective.
So we felt that that single fact the survival of one year was a very strong efficacy signal for the trial in the high dose group and we did believe that we’ve evidence of those responsiveness in both lung cancer and pancreatic cancer that then let us to do this 12 months treatment plan. And so, since we didn’t loss much alpha, we thought why not take an early look at this if there was more dose responsiveness and more duration responsiveness in the clinical effect maybe there could be something of that magnitude. So, that’s what we did.
If you use 80%(guessing here) 12 month survival rate for control arm, you may see
different results, I speculate the control arm is performing much better then the
SOC history indicates at first 12 month of the trial, IMO.
I am arguing HyperAcute may work on small number of patients very well,
but no effect on majority of the patients, hence no early separation, but
big fat tail KM curve, that is the risk we are trying to figure out.
Understand, but the curve separation has big meaning for second look too,
I may be wrong, here is how I see it. Next most of the 111 events may be coming
from the patients enrolled in the less than 24 month, and if the curves are separating
at 12 to 14 month time mark, then few 36+ month long term patients advantage in treatment
arm may not bring the P value to stop the second look, but final has a good chance
for success, IMO.
I am trying to argue with Jet that HR is the number that
determines the OS advantage, not the MOS. HR is determined
by the curve separation, earlier = lower HR, like I said before
if the IMPRESS trial curves separate at 6 month time mark with
a 5 month MOS advantage, 25 VS 20, should be enough to stop
the trial at first look. MDVN's trial was stopped early for only 2 month
MOS advantage but with HR=0.7, a 30% reduction in risk of death
compared with placebo, p less than 0.0001. I am not buying the NLNK's
view that " the reason was insufficient follow up due to over half of the patients being enrolled later in the game (they haven't/couldn't have enough follow up time yet) This has nothing to do with the shape of our curve."
Check out BMY's PIII CheckMate 066 which stopped today at clinicaltrials.gov,
the trial started on NOV 2 2012, and finished the enrollments for 418 patients
on Feb 28, 2014!
NEW YORK (AP) -- Bristol-Myers said Tuesday that its skin cancer drug nivolumab worked in a late-stage clinical trial, leading the drugmaker to end the study early.
I think BMY news today supports my view IMPRESS trial KM curves are not separating
early, otherwise first look should be a stop.
I see 60 is overcome tomorrow and 63 to 65 next Thur before the independent holidays.
No sellers, and the 4000K July options sellers many of which naked are under pressure
Company guidance is EBITDA of a $115 million to $135 million in 2014
and 2015 EBITDA with a range of $140 million to $185 million.
TJ Schultz - RBC Capital Markets
Hi everybody, good morning. I appreciate the guidance update certainly reflective of the strong market here. The range is fairly wide given, some of the take or pay contracts. So, I think Laura may be you touched on this a little bit, but if you could maybe discuss some of the factors driving you to the high and low end of these ranges whether it’s a more volume or price sensitive?
I would say it’s more volume sensitive and it really is dependent upon our ability to execute and bring the Augusta facilities online, the expansion of the Augusta facility online in the third quarter as we planned to do. I’m sure that happened and we probably are operating towards the higher end of that range as we are able to produce more sand to sell through the distribution business to those customers that don’t have contracts.
We can see the expansion of the Augusta facility online in the third quarter is the only risk
HCLP may not reach the high end of guidance which is very very low, so we may see street
raise 2014 and 2015 earnings estimates to 135/33.13=$4.07 and 185/33.13=$5.58 after Q2
earnings report in Aug, very likely with one more price increase in Q3 or Q4, IMO.
I do not think 70 will get the deal done. Three reasons:
1. ORCL wants and gets exclusive talks and ORCl better ready to pay
because it is not in best interest of MCRS not to let other also trying to
get in the deal(rumor SAP, IBM).
2. MCRS investment banker leaked the talks to get the stock price up to
argue for a fair buyout price, it is obvious OCRL is trying to low ball the
3. MCRS is buying back shares aggressively confident the shares are cheap.
With the strong business and with annual operating Cash Flow $240M cash
and strong cash balance, MCRS can buy back tens of million shares in few years
and share price will go up to 75 without buyout. It is very obvious ORCL wants
MCRS and MCRS wants a big fair premium in this kind of bull market.
Safety and tolerability assessments based on adverse events (AEs), clinical laboratory values (hematology, serum chemistry, coagulation studies, and urinalysis), standard digital electrocardiograms (ECGs), vital signs, and pulse oximetry [ Time Frame: From Baseline and up to 28 Weeks ] [ Designated as safety issue: Yes ]
My understanding is the trial is Double Blinded and Placebo patients will cross over to get
the drug treatments after they finish the 28 week trial. how can VRTX compare the two arms
of Safety and tolerability assessments if the trial finish at 24 weeks? Besides, the STRIVE trial
only had 164 patients and took 10 weeks to scrub and clean the data base for the results,
the two combo trials have 1100+ patients and have 6X more data to scrub and clean that takes
lot of time to do, any way that is just my guess according to VRTX history of reporting PIII results.
Correction, the two trials ended on May 2, 2014 and 10 weeks
is at July 11, My guess is the combo results at the earliest are
week of July 14, all IMO.
167 patients enrollment finish: Jan 12, 2010
48 weeks trial end: Dec 12, 2010
10 weeks after the trial end: Feb 22, 2011
Results news: FEB 23, 2011, exactly 10 weeks after the trial ends.
167 patients enrollment
The two combo TRAFFIC and TRANSPORT trial time line:
1100+ patients enrollment finish: OCT 18, 2013
28 weeks trial end: Apr 2, 2014
10 weeks after the trial end: July 11, 2014
Results out: July 1? or 2?, 2014