Ann: Kazia executes GBM Agile study agreement, page-45

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Merchant2000

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20/10/20

08:35

Post #: 48221068
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Originally posted by rikki: ↑

Correct Q they are certainly adding value:

By the end of Q1 next CY (2021), Kazia will have its drug:

• In 5 different clinical trials for 4 different indications
• Have completed 1 trial for its core indication,
• Completed 1 trial in an indication of high unmet clinical need,
• Started 1 trial in a new indication, and
• Started their drug in a pivotal trial that could lead to its approval.

That is a very full list of clinical activities.

And we are already heavily awarded by the FDA:

Paxalisib has been granted orphan drug designation (ODD) and Fast Track Designation (FTD) for GBM.

For DIPG, it has been granted ODD and Rare Paediatric Disease Designation (RPDD).

All of these designations aim to do the same thing and that is to make it as easy as possible for a company to produce

(A) the best quality clinical trial data to support its development candidates,
(B) the right data to support FDA approval,
(C) a high quality New Drug Application (NDA).

Where possible and within the FDAs rules and requirements, the FDA will provide incentives, such as shortened review times, market exclusivity and the possibility ofa Priority Review Voucher (PRV) for those with RPDD.

we are headed for a PRV with DPiG - this looks to be the desire given comments James has made.

though our GBM trial is already paid for... maybe it’s use will be fir drug 3!

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rikki
Great posting for your fans on HC
imo
Very early in game - market cap versus cash raised since 2015 !!!!!!

Research Quality of life with OS and PFS

and cost of treatment to patients etc

KZA Price at posting: 81.5¢ Sentiment: None Disclosure: Not Held
Upvote

0 Great analysis

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