Hi BTB,
This is awesome news! How many patients do we need for Interim Analysis again to take to the FDA? It’s n=72 & if you take into account we now have 44/75 actively recruiting, even if not yet recruiting PIs will be identifying suitable patients, until site initiation is completed & the green light given to commence - this isn’t even two patients per trial site in an Orphan Status (Rare disease) currently.
If all come onboard soon it’s roughly <1 patient per site. 3 patients per site is totally do-able to run smoothly if needed, event with multiple drug trials ongoing.
Something else also important is the “Intent to treat” population & that FSGS appears to be more common in black people & also those of Hispanic heritage. So take a look at trial sites, there is a lot of disparity in who gets recruited & benefits of clinical trials, white people suffer as well, but we want a representation of the FSGS sufferers in our trial & that may be interesting to you, as the FDA & World-Wide conferences are very much talking about inclusive clinical trials.
It’s a little different to REMAP-CAP & CLARITY 2.0 in that this Ph3 is Sponsor Lead (Dimerix) & an excellent Clinical Research Contract Organisation that deals with the day to day running of the trial, data collection portals & trial equipment. They are used often by Big Pharma trials also.
There has been a big shift in accommodating clinical trials with CRO’s & COVID-19, not only to support trial sites should they be affected by COVID-19, but also patients as well, to not miss visits (contingency put in place) with Decentralisation, that will not affect our data. A lot has changed in the last 2.5 years! We have been faring well. No reason we won’t on DXB also. It’s a vulnerable population with COVID-19, but so are other clinical areas.
This is great news!
- Forums
- ASX - By Stock
- DXB
- Ann: FDA IND Approval for Phase 3 Study of DMX-200 in FSGS
Ann: FDA IND Approval for Phase 3 Study of DMX-200 in FSGS, page-48
-
-
- There are more pages in this discussion • 2 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 DXB (ASX) to my watchlist
(20min delay)
|
|||||
Last
61.0¢ |
Change
0.055(9.91%) |
Mkt cap ! $335.3M |
Open | High | Low | Value | Volume |
57.0¢ | 61.5¢ | 56.5¢ | $1.938M | 3.305M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 3652 | 60.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
61.0¢ | 27035 | 1 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 3652 | 0.605 |
3 | 144496 | 0.600 |
2 | 28574 | 0.595 |
2 | 28532 | 0.590 |
2 | 24412 | 0.585 |
Price($) | Vol. | No. |
---|---|---|
0.615 | 17989 | 2 |
0.620 | 30000 | 1 |
0.625 | 43532 | 2 |
0.630 | 81378 | 5 |
0.635 | 123532 | 2 |
Last trade - 16.10pm 20/06/2024 (20 minute delay) ? |
Featured News
DXB (ASX) Chart |
The Watchlist
HAR
HARANGA RESOURCES LIMITED.
Peter Batten, MD
Peter Batten
MD
Previous Video
Next Video
SPONSORED BY The Market Online