Australia's largest stock trading and investment forum Australia's #1 stock forum

PAR

0.00%

26.5¢ paradigm biopharmaceuticals limited..

Over PAR, page-22

First 22 Last

Share
Profile

Follow
Nickporthcawl

1,554 Posts.

193

15/08/24

18:00

Post #: 75225873
Share

Originally posted by Babbanap: ↑

This is my opinion/viewpoint, only.

The TGA have the criterion that requires PAR to demonstrate they have a plan to provide further clinical information (Phase 3) within a set time period. We cannot satisfy that criterion unless we get the green light from the FDA. I would imagine the TGA do not want to open the gates to drugs that are not fully tested and proven, unless there is reasonable certainty that the proof is in the pipeline.

Even though we are only asking them for a determination to proceed with an application, and not for provisional approval at this point, they would not want us to proceed with an application if there was uncertainty about our ability to follow through with the necessary further data. As public servants with a duty of care to the welfare of the Australian public and the revenue provided by the Australian taxpayer, they could possibly see PAR's financial position as a matter for concern also.

In the same way a bank does not (normally) provide loans unless you demonstrate a capacity to repay, the TGA don't wouldn't want to allow experimental, albeit very promising, drugs into the market unless PAR has the capacity to complete the trials.

Expand

Good post Babba

Time is ticking to Pirates Day. There are no signs of a leaky ship. Anyone heard from @farmerbob

PAR Price at posting: 22.0¢ Sentiment: Hold Disclosure: Held
3 Upvote

0 Great analysis

Reply

Top Stories

M4M

Macro, Norden set up transport solutions initiative for West Pilbara

What's causing the cost-of-living crisis, and how to navigate it

SWP

Swoop lobs $18M offer at microcap telecom Vonex – in which it holds 19.9%

IRX

InhaleRX snags $38.5M in funding from VC biotech funder Clendon

MKT

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

NVU

Nanoveu surges 10% after benchmark testing for new AI chip begins

TLG

Talga Group wins key permit for flagship graphite mine in Sweden

MTH

Mithril's drilling in Mexico picks up silver at 997g/t, gold at 28g/t

SNX

Sierra Nevada raises $2M for silver exploration at Blackhawk

Week 42 Wrap: HotCopper's top picks; new ASX 200 record; world yawns at war