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Tuesday, August 20, 2019 2:07:55 PM
I know the company has been putting in a lot of good work on the pivotal PII AML trial over the past year. They've consulted with medical directors at Juno on the trial design to make sure they have the quickest possible path to approval. A big part of the trial design is getting the patients dosed 10-12 weeks sooner than in the PI. This could allow the overall timeline of the trial to be shortened by up to a full year. On top of this the trial design should allow for about 2-3 approvals in AML. While I wasn't able to get a set expectation on the timeline of the trial the hope is it should take up to 18 months. We will know more details very soon. If we dose first patient by EOY then that would take us out to roughly the middle of 2021. On the topic of how long to approval I was given Kite as a comparable example. They started their pivotal trial in mid-2015 and were approved in October of 2017. If we follow the same timeline we could potentially see approval by the end of 2022 if not shortly after. That's best case scenario but if we continue to see similar results to the PI it shouldn't be much longer than that.
This is obviously just one trial and we should see more results from the pancreatic trial as well. It will be interesting to see how they approach that one but I fully expect they attempt to partner it out. Either way it will only add value to the company.
It's certainly been one hell of a ride but it's not over yet. My patience has definitely worn thin at times but with a potential approval in less than 3 years I've been able to mostly ignore the day to day action. Until something fundamentally changes here I won't be going anywhere.
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