>>phase II data, when positive, is not a method to get MDs to prescribe drug - not in oncology<<
That's nonsense. I can give you dozens of examples of oncology drugs/indictions where positive Phase II data led to Compendium listing and off-label sales - including Nexavar in thyroid cancer and GIST.
You never posted here before but now are pontificating as if you are some kind of expert in ONXX and oncology. You don't have a clue whereas ocean is right on the mark. You are clearly some kind of trading basher or a basher. You don't know anything about ONXX the company, or the recent breast cancer trial data and what it means. You make a comment that Nexavar will only be for Kidney and HCC, when it is in 200 different clinical trials so that is utter non-sense. In addition, the growth in HCC sales alone makes ONXX an excellent buy.
With regard to off-label sales, Nexavar is already approved for two different indications. This makes is more amenable to off-label sales. In addition, it wouldn't be Nexavar alone but in combination with a proven anti-cancer drug, Xeloda, which also makes it more likely to generate off-label sales. The Xeloda combination also included some first-line patients, and this small set had longer survival than the Avastin treatments that is the gold standard. Granted it is small and there will likely be a phase III study, things bode well for Nexavar in breast cancer in the long term, and for off-label sales in the near term.
Now as far as the phase II data, even though PFS was excellent for Nexavr + Xeloda, the next key piece of data is median survival, which is not yet available. The same goes for Nexavar + paclitaxel. If the latter looks good, ONXX will likely proceed to phase III for that as well, perhaps in the current regimen, but there is also a good chance the regimen will be changed with regards to dosing schedules and dosages, perhaps in another phase II if changes are deemed to be needed rather than moving into phase III.
No - sorry. You are not in the business and there is NO WAY, MDs will start putting patients on this drug for breast unless phase III are quite successful in survival rates....
Three years wait minimum - if it gets there to phase III........this is the reality buddy - stop betting on hope. Kidney/Liver - that's it.
that is wrong in so many ways. But most obviously, if phase 2 data were not predictive of phase 3 results, then it is contradictory to argue that the outstanding ph2 results as second line tx are meaningless, and at same time argue that the borderline results as 1st line guarantee failure in ph3. Cannot have it both ways.
Anyone with 1/2 grasp of statistics can see that markedly positive results are most likely reproducible and borderline results can go either way when the subject numbers increase. Regression to the mean can only bring you back a ways. The outstanding results will not regress to be less than outstanding.
phase II data, when positive, is not a method to get MDs to prescribe drug - not in oncology. Sorry - you got it wrong. Secondly, success of phase II study, does not guarantee success of phase III - i.e. the key study to get NOC. Finally, the negative phase II will be demonstrated in a phase III, if they are dumb enough to invest in a phase III with same comparator. There is nothing else to analyze from this negative phase II.
Kidney and Liver - that;s it. Breast, 50/50 max. And if it comes, it's not before three years guys......good luck!
>>Over hype..there is less than 50/50 chance that this will work in phase III breast....<<
Not sure how you arrive at 50/50 given that Nexavar showed stellar, statistically robust benefit (prolongation of progression-free survival) when combined with xeloda in one phase II study, and a benefit as well when combined with paclitaxel in a second phase II study.
The Her2-negative population is a huge unmet medical need, and the phase II data will prompt Bayer to move Nexavar into pivotal phase III studies ASAP.