Shelly , our combo BLA should be finished in Decem
Post# of 148337
(Total Views: 398)
Posted On: 10/28/2019 6:45:33 PM
Re: Shelly2626 #10139
Shelly , our combo BLA should be finished in December , approval should be in about 6 months , but if FDA will feel kind they might approve in 4 months ..
I believe that our pivotal mono they need to wait for stability test for 350 mg dose , so sometimes in December they will be able to start .
Now when we have good results in TNBC , I believe it will be much easer to find patients , hopefully the 4 more patients they need to Dr Cristofanilli study will be enrolled this year , if results good in 6 months they will apply for BTD and very fast approval , so I believe TNBC will be approved 2H of 2020 .
With NASH look that we will have very good results in big animals in 7-10 days , and I believe soon after some type of partnership or BO.
They will not be doing this study alone .
All is good now , IMO
I believe that our pivotal mono they need to wait for stability test for 350 mg dose , so sometimes in December they will be able to start .
Now when we have good results in TNBC , I believe it will be much easer to find patients , hopefully the 4 more patients they need to Dr Cristofanilli study will be enrolled this year , if results good in 6 months they will apply for BTD and very fast approval , so I believe TNBC will be approved 2H of 2020 .
With NASH look that we will have very good results in big animals in 7-10 days , and I believe soon after some type of partnership or BO.
They will not be doing this study alone .
All is good now , IMO
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