Ann: Kazia's paxalisib obtains Rare Pediatric Disease Designation, page-81

Any one of those threads this morning, could be used to post.....but any possibility of an approach to the FDA seeking accelerated approval - would dramatically gap the stock. Just the mention by the company of this possibility, I think would be hugely market positive - simply because you can't have a market cap of US$50m and FDA marketing approval for a type, or any type of brain cancer drug. Can you ??

Two clear cut recent examples have just been presented - whereby the FDA are showing a less conservative, more empathic approach to early approvals. DIPG in 30 kids at St Jude, seemingly would carry high creditability, if in fact this trial is successful.

Investors would immediately have in mind the FDA Priority Review Voucher, which is probably worth twice as much as the whole company is now. Mind numbing stuff - or more correctly to say - this cap here is just too stupid for words.

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Interesting the CEO this morning used these words in the NEWS release to those registered, this morning:

CEO
"His discusses the potential of paxalisib as a treatment, recent clinical findings on the drug and how a clinical trial of the drug could potentially commence in Australia next year"


I do know from Facebook that Dr Dun is know to some parents in the St Jude trial. It does seem that Dr Dun has some involvement in this trial - that is a very good thing for researchers all around the world to share data.

Anyway these St Jude results are 4 weeks overdue from the original schedule from the company.....although I think in the last week, a new suggested timetable has been released. If the St Jude results are positive however- we surely must see a gap over $2 on the Priority Review and everything else associated with strong indications of GDC 0084 efficacy - that good results confirm