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

RAC

Click for more information

0.00%

$1.66 race oncology ltd

IND before Australian ethics?, page-13

First 13 Last

Share
Profile

Follow
Rossi70

4,138 Posts.

1412

24/03/24

13:39

Post #: 73031977
Share

Originally posted by Davisite: ↑

The EMA and FDA like to play leapfrog with their regulations with ever increasing paperwork requirements. The EMA upped their paperwork requirements in 2020 so they currently have the most stringent standards. Any drug that meets EMA cGMP regulations also meets FDA cGMP standards - of course until the FDA ups their requirements again.

The TGA has the least stringent paperwork requirements and you can use a new drug in Australia even if it doesn't meet the full EMA?FDA cGMP requirement (i.e. you can use it in patients if it is cGMP-like). This is one of the reasons Australia is such a good place to do Phase 1 trials.

The bottom line is by manufacturing RC220 in the EU to EMA cGMP standards we will have a drug that we can use in patients anywhere in the world.

Expand

Hi Davisite,

You are correct in saying about the European approvals.

1 of my other bio company, had EMA in 2017 and then last year received the new regulations approval.

While this company is not a drug company, yet it is a Medical Device, which had to re-apply again.

Below is a snippet of the announcement.

IMHO.

Regards

Rossi70

RAC Price at posting: $1.37 Sentiment: Buy Disclosure: Held
4 Upvote

0 Great analysis

Reply

Top Stories

SRN

Copper and zinc zone prove exciting news for Surefire close to WA's Yidby

DEL

Delorean unlocks $30M through Tanarra finance facility for bioenergy projects

Is the ASX getting its groove back? Here's 5 IPOs in September to watch

ADH

Adairs MD and CEO steps down after 17 years in company management

FEG

China's Xingye snags 19.99% stake in Far East Gold, eyeing latter's Indonesian gold play

First 13 Last

Add RAC (ASX) to my watchlist

(20min delay)
Last $1.66		Change 0.000(0.00%)		Mkt cap ! $282.8M

Open	High	Low	Value	Volume
$1.68	$1.68	$1.62	$102.7K	62.79K

Buyers (Bids)

No.	Vol.	Price($)
1	359	$1.65

Sellers (Offers)

Price($)	Vol.	No.
$1.66	249	1

View Market Depth

No.	Vol.	Price($)
1	359	1.645
1	48323	1.640
1	10000	1.615
1	19208	1.610
3	20625	1.600

Price($)	Vol.	No.
1.660	249	1
1.680	5000	1
1.720	580	1
1.730	25792	1
1.750	508	1

Last trade - 16.10pm 05/09/2024 (20 minute delay)

RAC (ASX) Chart