game changer indeed.. No longer possible to grab cheap shares from "confused...and concerned..." retail investors.
"On the flip side, control patients were older and had a lower KPS on avg"
That's not the flip side: both measures as you present them also favors the rindo arm. Of the three measurables you mentioned- extent of resection, age, and health (KPS score) all would favor patients living longer. Even if rindo had no effect on their outcomes, one would expect patients in the rindo+Avastin arm to outperform patients in the Avastin arm.
Now one can make guesses about how much of an effect these imbalances had and attempt to compensate for them, and the data still look promising.
Of course there are still many important factors that were measured that also have a big effect on survival. With such a small population, it is unlikely the arms were balanced in those factors also.
Taken together, its a nice pilot study that hints at efficacy but not enough for FDA approval.
In this case franks profit report is probably accurate. Careful followers of the Frazzano Phenomena will remember he changed his style of accounting for this position.
Instead of lumping all profits in a stock since birth into the cost basis of his current shares, the huge drop in his original EXEL position after a failure in a prostate cancer trial forced him to switch to a more traditional FIFO accounting for shares at low cost. That nasty hit from a few years ago disappears leaving only the recent gains.
Everytime you test for efficacy with an interim analysis you make the closing test more strict. It basically compensates for the extra chances you have to get lucky and meet the required p value even if the drug was not effective.
The final p value depends on how strict you make the required p values to stop at the interim checks.
Here they made them fairly strict so that the final required p value does not take a big hit.
The final N does not affect the p value you seek. A bigger N does make it more meaningful, however.
See, for example, the REACT study with small N and multiple peeks at the data and the FDA response.
The Phase 2 lead-in part of the trial in 120 pts showed statistically significant positive results.
Darn that FDA for requiring larger Phase 3 trials - would have saved investors a lot of grief if they just approved it last year after the first 120 patients.
"notorious for its inaccuracies shows 12.10 being hit today"
Or maybe they are psychic? The day is still young.
Most of the drugs that have received BTD status are in the same boat as CLDX - yet to receive approval pending results of PIVOTAL trials.
"The last sentence in the Results addresses the question of "chance", and the answer is: "OS analyses favor rindopepimut including when adjusted for various prognostic factors...""
There is quite a history of phase II results that "favor" the active drug leading to initiation of phase III trials (powered appropriately and designed so that adjustment is not so fuzzy) but not approval.
Instead of an expansion, why didn't they then run a larger study that could have led to AA or full approval? Shouldn't have taken too much longer and certainly would have been completed before ACT IV. They may still require another trial if they want recurrent on the label.
"confirming Rintega's efficacy" -- You keep chanting that but it isn't true.
"Turns out we were all wrong about the FDA" - You and my dog just ignore me.
"he results of ReACT were statistically significant, so the claim by FDA (probably in informal conversation) that results maybe "a fluke" due to small trial size is total garbage"
Take a look at the mathematics behind p values and you can see why the results in this small study are not sufficient for approval. This is especially true in GBM where there are so many other factors affecting survival that were not measured,and those that were had large differences.
The policy to not approve drugs based on hints of efficacy in small studies as proven wise in the past as Phase II wonder drugs go on to bomb in larger studies.
And the last time insiders purchased shares the price of CLDX was cut in half within a year.
"most probably have to do with targeting EGFRvIII cell indications "
Except that Keler keeps repeating (this time responding to a question at the same conference cal) that they did not find as much v3 as reported in the literature in the other indications and that they have no plans to try Rintega outside GBM.
"A holder of RCPT Sept $230 call will receive $240 in cash for a payment of $230"
No wonder they've been trading at a premium to the buyout price!!!
thanks for the post..always interesting to see how the not-so-bright crowd view things.
PS. This is the first post of yours where the correct statements outnumber the incorrect. (though it was close)
"CELG has made this a very quick tender"
You keep writing that but have yet to explain why you think that.
If anything, CELG is taking a bit longer than normal to complete the tender. The merger agreement gave them 10 days to begin the offer.
1. They could have just as easily negotiated for 5 days - a not uncommon figure in mergers.
2. They took the full 10 days to begin.
The tender is open 20 days because that is what the federal rules required. They could have announced a longer tender period but there is no point to (they will easily get the majority of shares tendered). 20 days is the law and is the norm.
If the ACT IV trial is stopped after the next analysis (unless for futility) that data - not yet final -would support a filing.
Except Marucci spelled out that "CBER has guided us that the small sample size would be a potential concern for them, if we were to file" and that the meetings have had some benefit as they had made "progress" in the areas of "manufacturing activities and the companion diagnostic." All drug applications go through give and take on the manufacturing so that should not be a show stopper.
The shocker of today was the comment "While this was a surprise to us..." as I thought I spelled out why this discouragement from the FDA was the likely outcome. Apparently CLDX is not reading this message board closely enough.
Your streak of "insights" continues!
Where you are mistaken in this post:
1. "HSR wait period termination late this week or early next week."
CELG and RCPT filed their required notifications on July 24. The FTC then has 15 days to act. That period ends tonight. Early termination next week or late this week is not possible.
2.. ."Nobody should think that HSR will stop the RCPT merger since the two parties do not compete now with each other."
The FTC also considers the future competitive landscape. While CELG and RCPT are not competing now, they both are developing promising oral treatments for IBD that would be going head-to-head in a few years if the early data are validated in pivotal trials.
The FTC may be unlikely to stop the proposed merger, but it would not be beyond them to delay it to give themselves more time or request more information.
That would be a concern to those short five 230 September puts.
Indeed. maybe the current value placed on it, though, would be lower if more posters recognized how competitive the costim space is.