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.
It is Merck that is known to have filed an opposition to the European patent. See the CLDX 10-K for a mention (although they don't give names). One other opposition was filed but the filer is hiding their identity.
That's the most direct competition for Varli (CD-27 agonist). These two proteins (along with a couple others) make up the TNF superfamily. When activated, they all promote T-cell survival.
All of these targets have agonist antibodies in development, often in combination with a checkpoint inhibitor.
The combo trials with Varli do not cover Varli with another agonist to this superfamily. Would seem rather redundant.
Bristol-Meyers is hedging their bets by testing their approved checkpoint inhibitors with both their internal program urelumab, and Varli. Celldex is testing Varli with a checkpoint inhibitor supplied by Roche, while at the same time Roche is working to overthrow the patent that Celldex licensed for Varli.
"There is nothing in the documents released yesterday that allows CELG to walk away in the event of an adverse event."
"RCPT does not sell any drugs and does not compete with CELG. "
How did I miss this post? C'mon broad_, just admit you are here to troll and are not really this poor of a reader.