2 billion dollar chatline favorite, being sold off due to issues associated with ultimate FDA approval for their drug, Confusion maybe a better word for the selling today and yesterday, in that company.
Maybe some contract here - The FDA hosted a March 2019 Workshop on Product Development for CNS Metastases....and has just released a paper on Cancer Clinical Trial Eligibility for Brain Metastases. Great information contained in this July 2020 paper - FDA discusses many issues including an undertaking to consider early approvals.(Current, relevant and very interesting info)
Few treatments are available for Brain Mets - the Kazia drug it would seem, is highly relevant to this FDA document.
Don't think a similar situation will develop with Kazia and the FDA.....it fact I am dam sure it won't. Check out who the FDA invited to their 2019 Brain Mets workshop, amongst a dozen or so people in total.
Patrick Wen (Workshop Co chair with an officer from the FDA)
Nancy Lin (Co chair on Brain Mets Development)
Priscilla Brastianos (Just a Star - my words)
Benjamin Ellingston (FDA subsequently endorsed B E imagining to make standard)
Anyway all there, invited by the FDA - best in the world - exactly the same people who has issued specific research, strongly endorsing GDC 0084. It is a dream for this small company to see this unfolding. Complete craziness is the market cap.
How much would that 2 billion dollar like to have these people on side.
If you do open the link for the FDA Brain Mets Workshop - suggest in particular look at the role played by Patrick Wen there, seemingly a person very close to the FDA.... Patrick took it upon himself to present results of the Phase 2 GDC 0084 Trial.
,
https://www.fda.gov/media/120472/download
https://www.fda.gov/media/121317/download
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