Could SGI-110 get accelerated approval? They know so much about how decitabine works, I wonder why they increased the pts load in mds/aml relaspe and refractory pts. Will this give them the ammunition too seek approval after ph2. The side effects are known to be better than either dac/vid. This is now showing significant delays in tumor growth in solid tumors.
The biomarkers evidence is also strong. They can now identify much earlier who is benefiting from these drugs. They have Stand up to cancer in their corner. The first data out of Stand up to cancer at AACR was about sgi-110. You lead in with your best drug. The FDA has mandated that they allow drugs to get approved faster, if there is evidence they will benefit unmet needs. AML/refractor/relaspe all fall in this category. This would allow for approved drugs to now combine with SGI-110 in trials that astex need not pay for? In MHO this has a shot at approval in 2014. If you disagree, then name one thing that SGI-110 has fallen short on. Just name one. Bet you can't.
There are now a host of bashers. My guess, they want shares of astex, but want a pull back. Specially anyone who sold shares in the $2.31 range and bragged about it. Seldom does a drug show this much good news and at the same time have few side effects.
Why did you choose to use this ID free? Are your other IDs busy being a s s h o l e s?
Note to the newer members of this message board. The id freetoquestionu is the same person as kyjellie and hatesupg. He is the only person who is KNOWN to use multiple IDs but when the heat is on him he accuses everyone else of being the same person. He is paranoid and delusional.
Well said Free. Posted this yesterday but any concern that they will not be presenting PH 1/2 data on SGI-110 at ASCO as was originally planned? They have chances to present later at other conferences.
Hadn't heard anything about asco. Where are you getting this info? My understanding that they will unvail the full ph2 results at ASH. They also stated the enrollment of additional pts would not affect data at ASH. The road to approvals is very broad for this drug. They can go after failed dac/vid pts, they can go after MDS or AML and there's evidence that they can benifit relaspe or refractory MDS and AML pts. Solid tumors will take a ph3 trial for any approval. I recall DR. M presenting one time, where he felt that generic dacogen would be timed, that SGI-110 would piggy back. I would not be surprised at ASH that we hear something about an accelerated approval pathway.
But unlike Dacogen only having 7 years of protection in the USA, because it took 13 years to get approved. I believe sgi-110 will have something like 15+++ years protection.