But statistical significance has little meaning in a setting like this one where there are many factors that would affect the results and so few patients. To say the numbers were statistically significant assumes that all patients were identical, obviously not true in a disease like GBM.
For the most obvious factors affecting survival - extent of resection and number of recurrences - there are clear differences in the two arms. One can try to account for this, but it is still a guess, and the results will certainly be less robust.
the trial was a success - exceeded their pre-trial measure of activity to warrant a Phase III.
Can anybody here name the line profile seen in the CLDX stock chart the first part of June 1?
Extra points for explaining what it tells us about the stellar atmosphere.
"Rintega FDA approval this year."
I'd be all over that bet. You know which side.
So why the excitement here for combo trials with Rintega/anti-checkpoint? If rindo is close to approval in both front-line and recurrent, and all oncologists are clamoring for it, then the rintega market cannot be increased.
" if there is a bid....he would have to disclose it "
No, Of course. CLDX would not have to disclose to anybody if they receive a bid and refuse it.
Yeah, I'm feeling a little peaked after ASCO.
My rintega market comment was more a swipe at all these posters who seem to be counting on 100% market penetration (and not just in GBM) from the start. Of course, it is good for humanity if the results can be approved. To answer my own question, if combining it with a checkpoint inhibitor prolongs PFS and survival then rintega, as it is currently used, would be needed for for even longer times and sales would increase.
I see little chance of approval this year, even if the FDA is receptive to a NDA, or the first futility/efficacy check is a roaring success. Takes at least a couple of months to put together an FDA and then more time until it is accepted then at least a few months until a decision, even if it has breakthrough status.
I expect that to be a moot point as my prediction is that based on the FDA meetings and the approaching final readout of ACT-IV, CLDX decides not to submit an NDA based only on ReACT. Question then is if they choose run a Ph III in recurrent or just wait for ACT-IV to readout.
I'm not excited about 1401, but if they can get that to amount to anything then it would indeed be big news.
"1) This $400 million is sales for only the "Recurrent" population, not the "Newly diagnosed, .."
That number is far too large to be recurrent market only. He is using a full year of treatment at $100,000/year
but very few patients will get 12 months of dosing. The overwhelming majority will receive two or three months worth if the ReACt trial is any measure of actual drug performance.
Plus, as Marucci described this week, if Rindo is used extensively in newly-diagnosed cases there won't be many cases of EGFRVIII positive recurrent patients in the future.
"Unless it's a tender offer for shares. That's what we really want to see."
What? A tender offer is made directly to shareholders. Even if CLDX ignored it, the potential acquiror would 1) announce it, 2) file documents with the SEC, and 3) mail those documents (via brokers) to shareholders.
In any event, CLDX is under no obligation to announce that it is in talks to be acquired or if it has already rejected an offer. Now if they sign a merger agreement then they are required to let you know. How else would you know when to vote or tender?
Why your preference for a 2-step offer (tender) vs a 1-step?
But isn't that down from the 27.26% forecasted earlier?
Never trust a report that doesn't understand significant figures.
"WOW where I went to school we have VASTLY different takes on Bio Science!"
That's an understatement .... Robert H. Smith School of Business, University of Maryland?
Xin chào cổ đông. Chúng tôi đang di chuyển công ty của bạn và vaccine EGFRVIII ngớ ngẩn đến thành phố Hồ Chí Minh.
What Frank is trying to say is that the definitive trial for Varli would be Varli+approved drug vs approved drug alone.
Frank, your reading comprehension leaves a lot to be desired:
"- No more than one prior chemotherapy-containing regimen for advanced disease.---This is good for GLEMBA......this is great!"
As presented by whipper, there is NO CHANGE in this aspect of the inclusion criteria.
Before: "...no more than 1 prior chemotherapy-containing regimen, for advanced (recurrent, locally advanced or metastatic) disease "
After: " No more than one prior chemotherapy-containing regimen for advanced disease."
"drugs that we know Glemba works well with such as Anti-CTLA4, PD-1, PD-L1-targeted immunotherapy" How do we know that? I think you are confusing some anecdotal evidence from 1401 (and even then ipi administration followed 1401 administration) or the preclinical work wih Varli.
This trial changes just reflects that when it was designed ipi was the only approved checkpoint inhibitor. now there are more and may be used in place of ipi.
"SQUIRE enrolled 1,093 patients (age ≥ 18 years, ECOG PS 0-2) with histologically- or cytologically-confirmed, stage IV squamous NSCLC,"
That "max price" has no relevance at all to the actual price at which the options will be granted. Could be much higher if the believers on this message board are correct.
"We just know that the results reached the P value for interim results (0.0019 or lower)."
Did BMY disclose the threshold for their trial. It need not be the same as EXEL used.
Your too kind. Nearly everything broad and south writes is wrong. Makes me think he knows that and is just having fun with the board.