Looks solid to me. Some had thought this might be the more difficult of the 2 P2s, and it came through solid (from early data).
With self titration you are expecting about the same on efficacy (the patient will push the button more often if in pain). And it did such in both arms. And the AE profile was clearly had better.
REALLY impressed with that .1 mg arm that a certain bull over on SA had already decided to be a failure.
Assuming clinicatrials.gov is correct (which it usually is for recruitment status) they started enrolling the NSCLC P2 trial 5/13 and stopped 2/14. That is not very long.
Before they could start enrolling the full 2B (200 randomized patients) they would have had to enroll the 27 patients in the 2A portion, treat them and get data. That sounds like a year or so easily.
I would find it difficult to believe that they ran the 2A portion, then recruited 200 more patients all in 9 months.
So yeah, sounds like the 2B was never launched.
Do have that billary trial FWIW.
I have no respect for Raj's CEO style.
I also have no respect for your racist attitude.
That info is in the SEC filing, so I have no idea why they do not answer you.
Aprox (i forget the exact numbers)
8M worth were converted.
33M worth were paid off
15M worth were rolled to 2018
35M worn were rolled to Set '15 under the ongoing conversion deal.
Now how I read the trial description.
The patients will be randomized prior to TURBT, so the bleeders will still be in the ITT population. If a patient is randomized to the Apaz arm, and is a bleeder, they will recommend the doctor not treat with Apaz. But these patients would still count under the Apaz stats because that is how trials work.
It is basically the same as in any trial when patients discontinue the trial drug. They still count in the stats because they reflect how the drug will actually be used in the real world.
Also, that p=.001 number is very retrospective and means little.
That said, if the blood effect is real I would think the new trial has a decent chance of working. We will know in 3-4 years?
dcaf, of course size matters. But 2 year recurrence vs recurrence rate? I would expect a better P off the recurrence rate (which I would take to be log-rank of the K-M curve) as it has more data to work on. Not really certain though and might dig around.
It would certainly not surprise me to see the FDA not approve the NDA to be submitted on the 2 older studies, regardless of the progress of the new study.
But the quote you posted does not say that. It is clarifying what a SPA is in general. It is generic standard boilerplate material.
Here is the full paragraph:
About Special Protocol Assessments
A Special Protocol Assessment is a written agreement between a Sponsor and the U.S. Food and Drug Administration on the design, execution and analysis for a clinical trial that may form the basis of a new drug application, or NDA. Final marketing approval depends upon the efficacy results, safety profile and an evaluation of the risk/benefit of treatment demonstrated in the Phase 3 clinical program.
Superiority in this context is a statistics term, not a clinical term. It is quite possible for a drug to be stat superior yet not clinically better (see Zevalin). It is also possible for a drug to be only non-inferior yet clearly clinically better,
We really need to see the whole enchilada before we know the degree to which 2012 is clinically the better drug.
I am glad they are getting a SPA for the 2012 trial. That was always going to be slightly tricky design, and it is a hell of a lot better seeing the FDA sign off on it than seeing Raj do such.
I still could care less about Apaz.
I would certainly not expect results in 2016. I would be happy to see a trial started by end of year.
And that 90% power for NI and 80% for superiority seams weird to me. It would seam to imply a small NI margin, but why would SPPI try to push that? A larger margin would certainly make it easier for the trial to work.
As of June 30, DL completed the $2B share buyback started in 2014. This totaled about 44M shares.
They have just recently authorized a new $5B buyback to complete in '17 (I think).
The numbers only come out quarterly (go to the 10Q/K and search for "repurchase"). If you really did mean a real time number, I am not aware of any such data.
Well, finally one PPHM long, BioBS, weighed in against the venom. BDU also was anti, but he a vocal short so does not count.
i would be certain that MD2512 also would be strongly against such, especially as the group attacked him for trying to be reasonable.
Curious where the others on that board will stand on this disgusting behavour.
Three "respected" posters are having a love fest calling for PPHM non believers (or even partial doubters) to die of cancer.
Started with volgoat:
"i'm waiting for the day DEW gets cancer, will be a great day. :)
and all others that bash cancer companies. Karma is a beotch.
a slow painful death would be the best case scenario:"
And supported by eb and couch..
Curious is wookie will weigh in over here (I assume the IHub posts will soon be gone).
I would think the primary endpoint (OR) is already well established and the secondaries are reasonably mature (17 months since last enrollee).
The timing here slightly puzzles me. I would have thought they would have planned to release the primary OR data months ago, and update PFS/OS as time when by.
Regardless, agree that we should have data soon.
Still saying Q3 for the data from the 2nd P2 for TRV130, but clinical trials .gov says Jun so hopefully it will be within 1-2 months.
I would suspect late Q3 or Q4 we would hear word on the P3 trial plans for 130 (still saying they hope to start on Q1 '16, but would be nice to hear some more details).
The heart failure drug (027) is looking at Q1 '16 for data. This one has a go-nogo by their partner which could provide a milestone payment.
And that is about it for anything that can actually move the stock.
Only about $10M ( and that is next Q).
But that's a start. Should be at $40M/Q or so by EOY. Add that to cash in hand of about $200M and things are OK by me.