The CEO has disclosed on half a dozen recent occasions in...

The CEO has disclosed on half a dozen recent occasions in presentations...they are preparing a NDA (new drug application FDA) now- for their phase 3 drug, paxalisib in brain cancer. (One in six drug are now approved prior to completion of phase 3 - but sure, the FDA say the phase 3 must still proceed to completion.)

Yet the company is caped at US$170M  (they have almost almost US$30M cash and no loans).......  given the start of the NDA application is happening , according to the company - how can this market cap today, be reconciled with the value of, FDA marketing approval for a new brain cancer drug.

In little know information - the FDA granted Kazia orphan drug designation way back in Feb 2018, and more recently FDA Fast Track Designation. See stories which explains these orphan and fast track approvals, and more about the company and its drug.

Big data readouts are expected over the weekend.....for brain metastases clinical trials which exclude or are different to this NDA.  

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For any new investors looking at this stock for the first.....it is suggested there is no catches here - the company has many clinical trials paid for by groups like the US National Cancer Institute, Harvard University and cancer research international consortiums.

Just no real explanation as to why the SP is what it is......but as I say, for new people here, enjoy the research. You may never have seen anything like it.

Indeed when you are researching and finding items of interest  - thinking oh this is good.......well its gets better, much better) , if people read and undertake their own research.


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Kazia Receives FDA Orphan Designation for GDC-0084

February 28, 2018 

SYDNEY, Feb. 23, 2018 /PRNewswire/ — Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kazia's investigational new drug, GDC-0084, for the treatment of glioblastoma multiforme, the most common and most aggressive form of primary brain cancer. The company received written notification from FDA on Friday 23rd February 2018.
Key Points

• Orphan Drug Designation (ODD) is a special status accorded to drugs which are considered promising potential treatments for rare ('orphan') diseases, generally defined as those which affect less than 200,000 cases per annum in the United States
• ODD can provide drug developers with up to seven years of Orphan Drug Exclusivity (ODE), extending the effective life of a commercial product. It also provides opportunities for grant funding, protocol assistance, and financial benefits, such as a waiver of New Drug Application fees, and tax credits
• Licensed from Genentech in October 2016, GDC-0084 is due to commence a phase II clinical trial in glioblastoma in late March or early April of 2018

Glioblastoma multiforme (GBM) is an area of significant unmet medical need. More than 130,000 patients are diagnosed worldwide each year, and the prognosis remains poor, with median survival of 12-15 months on best available care. Existing drug treatments are largely ineffective in almost two-thirds of patients, and there remains an urgent need for new therapies.

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Kazia Therapeutics’ (ASX:KZA) paxalisib granted FDA Fast Track Designation

Health Care

ASX:KZA 20 August 2020

Samantha GoerlingSenior Presenter and Markets [email protected] August 2020 13:45


CEO, Dr James Garner (second from left)
Source: The Australian

• Kazia Therapeutics (KZA) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for paxilisib as a treatment for glioblastoma
• The designation accelerates the development of new drugs which have the potential to fill gaps in the treatment of serious or life-threatening diseases
• Practically, it provides a 'rolling review' of a New Drug Application, allowing for sections to be assessed as they become available
• Kazia intends to begin preparing activities for the application next year
• Shares have been trading 35.8 per cent higher at $1.12

Kazia Therapeutics (KZA) has been granted Fast Track Designation (FTD) for paxilisib, previously GDC-0084, as a treatment for glioblastoma.
The U.S Food and Drug Administration (FDA) FTD accelerates the development of new drugs which have the potential to fill unmet needs in the treatment of serious or life-threatening diseases.
Kazia CEO Dr James Garner said the FTD will afford the company notable time savings in the drug's development.
"In awarding Fast Track Designation to paxalisib, the FDA has recognised the drug’s potential to meaningfully improve outcomes for patients with glioblastoma. This is a very powerful acknowledgement," James commented.
"The opportunities that Fast Track Designation creates, as we move towards a New Drug Application filing, are of great value and have the potential to substantially accelerate the commercialisation of paxalisib," he added.
Practically, the designation provides the Australian oncology-focused biotechnology company with greater access to the FDA and makes paxilisib eligible for an accelerated approval and priority review when a New Drug Application (NDA) is submitted.
Additionally, Kazia can access a 'rolling review' of an NDA for paxilisib, allowing for sections to be assessed as they become available.