RE:RE:RE:RE:RE:RE:Pelareorep in 3rd line HR+/HER2 negative breast cancer
This might be a meaning back and forth as I always thought that AA was possible with the right trial setup and at least you have finally recognized that AA was not possible with the previous trials that onc had done as you had always touted that they were applying for AA with the results they had so at least we are getting somewhere.
So moving on
As for how quickly they could enrol is subjective as most likely the company will be competing with multiple companies for patients. I will admit I have no idea how long it will take but past history with our company and others shows it could easily take over a year and most likely 2 to enrol all the patients IF things go well and then they have to wait a pre-determined time whether it is 16 weeks or more to get a read out from the patients for any sign of efficacy to see if they can even apply for AA as Kirk stated himself. And then no guarantees that the fda will accept the submission. Best case scenario is it all works out and in a couple of years they apply for AA and it is accepted and off to the races, worst case is the trial moves on to the phase 3 portion and it will be another couple of years and by then the patents will be gone so where does that then leave us.
The best case scenario for the company is that they get BO with the potential that COULD be there so first off let's hope that the upcoming OS for the mbc is stellar.