@dachopper
You are absolutely correct, this is because the NYHA classification is very subjective. See below of an extract from an article:
"The survey of cardiologists showed no consistent method for assessing NYHA class and a literature survey showed that 99% of research papers do not reference or describe their methods for assigning NYHA classes. The interoperator variability study showed only 54% concordance between the two cardiologists."
However, no one can miss diabetic/ischemic classification; furthermore, there seems to be a bidirectional link between diabetes and heart-failure. exert from this article write: "People who have Type 2 diabetes, characterized by elevated blood sugar levels, are two to four times more likely to develop heart failure than someone without diabetes. But heart failure, a condition in which the heart fails to efficiently pump oxygenated blood through the body, also is a risk factor for diabetes"
I also agree with you that our target population for the next trial should be 1) CRP >2 (inflammation), 2) NYHA class II - III (but the study will enriched for class II, as many class III patients have too much scare tissues already in the heart) 3) diabetic/ischemic patients (either as an inclusion criteria OR as a pre-specified subpopulation)
Ideally we would ignore class III patients, but since it is so difficult to discern between class II & III, it is wiser to include both into the next trial, whatever the next trial may be (either another phase 3; or a phase 4 (slim chance)- if we get Accelerated Approval for the diabetic/ischemic group).
The meeting with the FDA will be interesting, because if we have to wait for another phase 3 trial, that's at least 4-5 years before we see any results, during which more patients would have died from HF.
- Forums
- ASX - By Stock
- Ann: Biotech Showcase 2022 Presentation
@dachopperYou are absolutely correct, this is because the NYHA...
-
-
- There are more pages in this discussion • 26 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 MSB (ASX) to my watchlist
(20min delay)
|
|||||
Last
$1.04 |
Change
0.060(6.15%) |
Mkt cap ! $1.181B |
Open | High | Low | Value | Volume |
97.0¢ | $1.04 | 96.0¢ | $6.538M | 6.424M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 9000 | $1.03 |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
$1.04 | 118502 | 6 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 9000 | 1.025 |
1 | 53215 | 1.020 |
4 | 42253 | 1.015 |
4 | 91264 | 1.010 |
4 | 119264 | 1.005 |
Price($) | Vol. | No. |
---|---|---|
1.035 | 118502 | 6 |
1.040 | 154541 | 7 |
1.045 | 78950 | 5 |
1.050 | 123069 | 11 |
1.055 | 182870 | 4 |
Last trade - 16.10pm 20/09/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |