(Total Views: 472)
Posted On: 10/16/2020 2:37:56 PM
Post# of 154899
This may not be relevant to anyone, but I thought I'd do some digging on IMMUs timeline since it sounds like they had some road bumps. I don't know when they first started sacituzumab trials but it was back several years. (As I tried comparing to cydy timeline) so IMMU
May 2018 submitted bla
July 2018 FDA accepts application
January 2019 FDA rejects submission( manufacturing I think, not drug efficacy)
February 2019 CEO gone
December 2019 bla resubmitted
April 2020 FDA approved
September 2020 gilead purchase offer
Looking at that it took 12 months post rejection to resubmit bla. I don't know what their funding situation was. Just trying to get an idea of another company that went through similar circumstances.
I also see hgen was told to finish their trial and their shareholders are like many people who own shares of a potential covid therapeutic thinking they have the magic covid elixir. They also have gilead in their back pocket.
So a trial continuation wouldn't surprise me. NP said it was the most likely scenario on Dr been interview, so expectations were appropriately set. At least in my world.
May 2018 submitted bla
July 2018 FDA accepts application
January 2019 FDA rejects submission( manufacturing I think, not drug efficacy)
February 2019 CEO gone
December 2019 bla resubmitted
April 2020 FDA approved
September 2020 gilead purchase offer
Looking at that it took 12 months post rejection to resubmit bla. I don't know what their funding situation was. Just trying to get an idea of another company that went through similar circumstances.
I also see hgen was told to finish their trial and their shareholders are like many people who own shares of a potential covid therapeutic thinking they have the magic covid elixir. They also have gilead in their back pocket.
So a trial continuation wouldn't surprise me. NP said it was the most likely scenario on Dr been interview, so expectations were appropriately set. At least in my world.
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