KZA 0.00% 8.0¢ kazia therapeutics limited

Some obviously do not understand the significance of accelerated...

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    Some obviously do not understand the significance of accelerated approval:

    https://www.prnewswire.com/news-releases/us-fda-awards-fast-track-designation-ftd-to-paxalisib-for-glioblastoma-301115307.html

    https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

    "Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit."

    "We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit."
 
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