What an excellent post and what we do know on GDC0084 is...
Jame Garner has said we have efficacy now and it was in late stage patients at the time and we know that PI3K inhibitors are highly targeted and of the class of PI3K inhibitors GDC0084 is not prone to some of the side effects that others are and so doses could be raised and generally the higher the dose the better the outcome as long as you keep an eye on tolerability... GDC is very well tolerated.
rewatch this from earlier:
https://m.youtube.com/watch?v=nFUVvQwjlqMDr Dun has said that the drug prolonging Little Josie’s life IS GDC0084 with her expected life of 10 months she’s now at 21 and counting - sadly it won’t go on forever but he tried it in his ‘patient/daughter’ she is responding - he credits it to GDC0084 - if it extends life by double or more and sees patients expected life progress from 10 months to add a year or so beyond 22 months then there’s no doubt we have a beneficial drug in an untreated decease and given the figures above we at least perform as well as Temozolomide
We have a generic name assigned now and of course all our collaborations which some pass of as just normal practice yet also cannot offer any other case of such interest in any other compound. And of course Orphan Drug Designation which allows fast tracking.
it’s clear to me we are not waiting on efficacy - I think that is already unofficially established in the comments from Dr Dun and our conservative CEO James himself - we also already know GDC0084 is well tolerated in its class and the class is highly targeted - for me it’s more about what levels of efficacy do we have and Temozolomide offers a true benefit BUT also seems like a bench mark that’s completely attainable given what we know from GDC already and from these two highly qualified gentlemen.
I think our big news will be ‘yes’ the results we have do warrant this drug going to market... but of course the research must be qualified in its actual data - I just cannot see either Dr Dun or James making deliberately misleading states and James has said, paraphrasing - ‘ I think we can say with a fair degree of confidence that GDC0084 shows a benefit’
We just need the final statistical data to know the range of efficacy is it for 35% of patients - is it for 60%, does it a meaningful add 3-11 months (as released drug Temolozomide) of life or is it greater than this.
So it’s not a matter of if it’s a green light for me more how green is this...
3 weeks to go.
