“In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children, and the urgent unmet medical need.
A clinical benefit of Elevidys, including improved motor function, has not been established. As a condition of approval, the FDA is requiring the company to complete a clinical study to confirm the drug’s clinical benefit. The required study is designed to assess whether Elevidys improves physical function and mobility in ambulatory DMD patients with a confirmed mutation in the DMD gene”
i
Interesting also how much consideration and lee-way the new approach FDA has to NEW products. You missed that cherry picker. Funny that.
2023 The Final Countdown, page-711
-
- There are more pages in this discussion • 2,693 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.13 |
Change
-0.025(2.17%) |
Mkt cap ! $1.284B | |||
| Open | High | Low | Value | Volume |
| $1.15 | $1.16 | $1.11 | $7.363M | 6.488M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 5 | 94863 | $1.13 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.13 | 5000 | 2 |
View Market Depth
| Last trade - 16.10pm 26/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |