Likewise! Its not an outright rejection, because if you read the regulations - https://www.ecfr.gov/cgi-bin/text-idx?SID=267602869dc495c1d59379706cf83c90&mc=true&node=se21.5.314_1110&rgn=div8 and
the reasons for an NDA refusal here - https://www.ecfr.gov/cgi-bin/text-idx?SID=267602869dc495c1d59379706cf83c90&mc=true&node=se21.5.314_1125&rgn=div8
The FDA just wants more evidence. Its not a rejection of the current evidence.
Its stem cells. Its a revolutionary method here.
The best case scenario is to see approval via the accelerated approval pathway, and then a post-marketing study as a condition in the approval.
This I believe will be given because its a huge unmet need!
Next steps discussion, page-7
-
- There are more pages in this discussion • 46 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
$1.02 |
Change
0.015(1.49%) |
Mkt cap ! $1.164B | |||
| Open | High | Low | Value | Volume |
| $1.00 | $1.04 | 94.0¢ | $11.76M | 11.90M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 6 | 206912 | $1.02 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.03 | 37637 | 1 |
View Market Depth
| Last trade - 16.10pm 31/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |