I’m aware of three expected scheduled readouts - but there may be some new surprise IE collaboration as in the new lymphoma study recently announced:
in practicality we have our phase 3 pivotal study starting, but,
in theory we can be approved in any one condition at phase 2 and we - x3 phase 2 Studies underway and with one more about to start in January
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many drugs have been approved in phase 2 data alone...
lung cancer drug, ceritinib, received approval based on Phase 2 trial results showing an overall response rate for more than half of patients over seven months....
paxalisib works in 65+% of patients and extends life by 61.5% over the current standard of care Temozolomide
https://www.appliedclinicaltrialsonline.com/view/impact-faster-drug-approvals-oncology-clinical-trial-design
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1out of 8 drugs which are new orphan drugs or cancer drugs approved on one trial
Most recently, IQVIA released a report finding that 25 of 59 (42%) novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials. But as in previous years, a large portion of the drugs relying on only one trial were new orphan and cancer drugs.
Paxalisib has a new orphan drug designation and is About to be x4 phase 2 trials... multiple shots on goal!
https://www.raps.org/news-and-articles/news-articles/2019/5/almost-half-of-all-new-drug-approvals-in-2018-reli
These very exciting times for holders of Kazia with paxalisib in multiple phase 1 and phase 2 trials with an orphan drug designation and a potential PRV worth hundreds of millions in compensation
its taken years to get here and the market has not yet caught up with where we are at - but it will eventually - as we are fully funded through our new phase trial and the next couple of years as per the recent Excellent interview we have all seen
I’m aware of three expected scheduled readouts - but there may...
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