Congrats Paradigmers - Paradigm is in discussions and forming a relationship with the FDA. It seems I was correct about cGMP delaying the submissions.
People might think this isn't big news, as it only treats 10 people but I'd like to point out a few things about the "Early Access Program" in the United States.
The FDA will only grant an EAP to a drug if it ticks all these boxes:
* Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
* There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
* Patient enrollment in a clinical trial is not possible.
* Potential patient benefit justifies the potential risks of treatment.
* Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
It's actually a high hurdle to overcome, so if Zilusol is approved, you can bet the FDA is taking OA as a serious disease and that they are impressed by the data package PAR has submitted in their FDA.
I would love to be a fly on the wall when Paradigm casually drops to the FDA that they see a reduction in BMEL through objective MRI scans, and potentially Disease Modification.
Anyway, great news, FDA & PAR are talking. Big Pharma will see the IND being filed. Not too long now for the Australian TGA Provisional Approval submission that, (apart from a commercial deal) will be the near term catalyst for real fireworks in the share price.
- Forums
- ASX - By Stock
- PAR
- Ann: PARADIGM FILES FIRST IND WITH US FDA
Ann: PARADIGM FILES FIRST IND WITH US FDA, page-3
-
- There are more pages in this discussion • 17 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add PAR (ASX) to my watchlist
(20min delay)
|
|||||
Last
19.0¢ |
Change
-0.010(5.00%) |
Mkt cap ! $66.54M |
Open | High | Low | Value | Volume |
20.0¢ | 21.0¢ | 19.0¢ | $203.4K | 1.019M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
14 | 387930 | 19.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
20.5¢ | 65468 | 2 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
13 | 384246 | 0.190 |
3 | 57000 | 0.185 |
8 | 194873 | 0.180 |
6 | 140904 | 0.175 |
7 | 595605 | 0.170 |
Price($) | Vol. | No. |
---|---|---|
0.205 | 65468 | 2 |
0.210 | 25992 | 3 |
0.215 | 30000 | 1 |
0.220 | 27066 | 4 |
0.225 | 21604 | 2 |
Last trade - 16.10pm 27/09/2024 (20 minute delay) ? |
Featured News
PAR (ASX) Chart |