PAA

0.00%

20.0¢ pharmaust limited

The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-884

First 884 Last

Share
Profile

Follow
enkayess

221 Posts.

126

13/03/24

10:59

Post #: 72861692
Share
Originally posted by Wanderdog: ↑

One other question, and thanks for those that replied, after the trial, which I see may be shortened from the traditional 3 years to less, PAA then produce the final report even if the trial is stopped short from good preliminary results, PAA still have to produce the report to the FDA for fast track approval? This report takes 6 months, then there is a 6 month review period by the FDA. This is still an additional year. I am trying to develop a timeline until we are on the shelf.

Our CEO has stated that the trial should start in the 3rd quarter of this year. This is a Phase 2 study, as that is what comes after the Phase 1 study, but if it shows promising results which look like it will, then this can be rolled into the Phase 3 study? Can it be called a Phase 2/3 study already, I know our CEO calls it that but I do want to see the FDA call it that from the outset but cannot see where they have at present, until during the Phase 2 study when preliminary results are reported on.

Please don't interpret this wrong as I hold PAA, but timeframes are becoming a little optimistic from my knowledge of this sector but happy to be corrected. Timeframes are as below:

Submission of methodology proposal for Phase 2 trail, PAA state from 6-9 months time this will be delivered to FDA.
FDA acceptance of methodology of trial - 3 months
Phase 2 averages 6 months to 2 years, plus FDA review period of 6 months.
Phase 3 averages 2 to 3 years, plus submission of data 6 months, plus FDA review period of 6 months.

time to on the shelf - June 2026 best case, standard case scenario June 2029

Expand

Not sure if you have seen this, may assist:
PAA Price at posting: 35.5¢ Sentiment: Buy Disclosure: Held
13 Upvote

0 Great analysis

Reply

Top Stories

ITM

Fast-track assaying yields 182 g/t gold for iTech at new NT play

Climate change to drive market trends to the moon

Has uranium run out of steam? An update on nuclear markets & developments ahead in FY25

The Big Deal: Free-to-air TV swings the axe, but will it be enough as enormous sports deal bills loom?

LLL

Leo Lithium announces major divestment of flagship Goulamina project to Ganfeng

Week 27 Wrap: "Election year" is here as UK Labour win contrasts France; Trump wins immunity & annual report season hushes ASX

KGL

KGL sniffs 19% Cu from drilling at Rockface play in NT

STN

Saturn’s stars have aligned for the gold explorer’s Apollo Project

TVN

Tivan and EARTH AI gear up to commence fresh drilling at Sandover lead-silver project, NT

RHI

Red Hill Minerals Signs $6.5 Million Agreement with Peel Mining to Explore Curnamona Project, NSW

There are more pages in this discussion • 541 more messages in this thread...

First 884 Last

Add PAA (ASX) to my watchlist

(20min delay)
Last 20.0¢		Change 0.000(0.00%)		Mkt cap ! $89.00M

Open	High	Low	Value	Volume
20.0¢	20.0¢	19.3¢	$112.4K	570.1K

Buyers (Bids)

No.	Vol.	Price($)
1	71364	19.5¢

Sellers (Offers)

Price($)	Vol.	No.
20.0¢	457262	6

View Market Depth

No.	Vol.	Price($)
1	71364	0.195
19	583155	0.190
28	1152549	0.185
19	993658	0.180
10	743068	0.175

Price($)	Vol.	No.
0.200	457262	6
0.205	202546	7
0.215	206000	4
0.220	109118	1
0.225	62500	1

Last trade - 15.59pm 05/07/2024 (20 minute delay)

PAA (ASX) Chart

The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-884

Fast-track assaying yields 182 g/t gold for iTech at new NT play

Climate change to drive market trends to the moon

Has uranium run out of steam? An update on nuclear markets & developments ahead in FY25

The Big Deal: Free-to-air TV swings the axe, but will it be enough as enormous sports deal bills loom?

Leo Lithium announces major divestment of flagship Goulamina project to Ganfeng

Week 27 Wrap: "Election year" is here as UK Labour win contrasts France; Trump wins immunity & annual report season hushes ASX

KGL sniffs 19% Cu from drilling at Rockface play in NT

Saturn’s stars have aligned for the gold explorer’s Apollo Project

Tivan and EARTH AI gear up to commence fresh drilling at Sandover lead-silver project, NT

Red Hill Minerals Signs $6.5 Million Agreement with Peel Mining to Explore Curnamona Project, NSW

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-884

Top Stories

Fast-track assaying yields 182 g/t gold for iTech at new NT play

Climate change to drive market trends to the moon

Has uranium run out of steam? An update on nuclear markets & developments ahead in FY25

The Big Deal: Free-to-air TV swings the axe, but will it be enough as enormous sports deal bills loom?

Leo Lithium announces major divestment of flagship Goulamina project to Ganfeng

Week 27 Wrap: "Election year" is here as UK Labour win contrasts France; Trump wins immunity & annual report season hushes ASX

KGL sniffs 19% Cu from drilling at Rockface play in NT

Saturn’s stars have aligned for the gold explorer’s Apollo Project

Tivan and EARTH AI gear up to commence fresh drilling at Sandover lead-silver project, NT

Red Hill Minerals Signs $6.5 Million Agreement with Peel Mining to Explore Curnamona Project, NSW

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News