Why don't you compare to FBIO who works with City of Hope Hospital on two CART projects with mktcap $0.175B. Only 1/20-1/30.
I don't have my simulation crystal ball at hand now since I am not at home. But still can do a rough estimate. Assume everolimus has 7 months, on 07/01 this branch may have about 77% PFS events. For a total 69% events, cabo should have 61% events. For a 15 months estimate time, my gut feeling is about 11 months. 11 vs 7, not too much to worry about.
If our interim analysis(I mean the analysis being done just now) of OS shows the very high possibility trend of 60 months, I know it's hardly possible, you can bet your farm that FDA will give us breakthrough status without any formality.
Anybody wanna count cars on parking lot this weekend? And check whose credit card was paying the pizza. That's Peter Lynch's approach.
I have asked one question months ago and would like to ask once more about this trial.
IF cabo has been approved for second line RCC, and then this trial is a success(better than or non-inferior to sunitinib), will EXEL be able to use these NCI-sponsored phase II trial's data to request FDA to move cabo to first line advanced RCC?
That's why I think a peek into OS is important. The future of cabo and exel depends more and more on trials with OS as primary endpoint. We cannot afford to go after only PFS.
Let me revisit my crystal ball. Let's assume cut off date to be 7/1/2015. If we want cabo branch to be 15mos, since cabo branch contributes 50%/2, the afi branch should contribute 90%/2. Afinitor's PFS should be less than 5mos. The reading from history, aff's PFE were 4.8-6. To be safe and fair, I always give it 6mos. My conclusion is 13-14, a little more than double or half year ahead. I don't worry about PFS, or approval. Just eager to see if half year's PFS increase can translate into some OS benefits. A peek into this not-matured analysis may give us some hints.
Any chance just give us PFS readout, and then continue with other analyses like safety, OS, pharmacokinetics, etc.
That's possible since PFS itself is the very criterion for cutting-off. The second that portion of patients is unblinded, PFS is over there.
yeah, if our two lung cancer phase II trials may suffice for FDA approval......
7 months for everolimus? Not a big deal. Even everolimus has 7 months PFS, cabo still much longer than #$%$ very simple: if both are 7, we've already reached 69%.
PFS is not a problem. By no means, affinitor can reach 12 months PFS with every trial indicated around 6 months. What's interesting is the peek of OS data. Will half year of extra PFS translate into meaningful OS. That's the biggest question for cabo's future plan.
If we had a deep pocket, the phase 3 trial has already been recruiting. HCC is slow and NSCLC has not started, seems some big guy told MMM to hold lung cancer trial so they can design the trial by more experienced scientists.
If a company is a prey of big companies, its price can be kept very low. The big one will snap it at low price. The two companies I owned with very very successful products were stolen were: MEDX and MITI.
Let's assume cabo has already been approved for 2nd line RCC, and it beats Sunitinib with statsig in PFS and OS. And NCT01835158 is a head to head compare with existing 1st line drug with 150 patients. Is it enough for EXEL to ask FDA to move cabo up to 1st line?
The 5 v 7.5 assumption is broken. Smashed! The focus is on how afinitor is behaving comparing to expectation.
If it's still 5, our PFS is getting closer to expected OS.
Thx. So, mostly you were focus on drug concentration and metabolism, not related to pathology, right? Would that applies to any other chemicals?
Social, I remember once you said cabo has a better chance in HCC than RCC. Would you tell us the biochemical mechanism behind it? Thx.