Does anyone understand the implications of No EIR (Establishment Inspection report) announced?
As per FDA rules, tThis must have been announced at least 3 weeks before PDUFA date.
So, no anouncement means it's positive? is EIR mandatory to be notified to the inspectee?
Is Mesoblast liable to announce the receival or report to ASX as per law?
In case EIR is delayed, can it be an indication of possible delay in PDUFA date?
As we get closer, more unexpectedly missing things create anxiety.
all valid questions.
2023 The Final Countdown, page-1771
-
- There are more pages in this discussion • 1,633 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
97.0¢ |
Change
-0.010(1.02%) |
Mkt cap ! $1.107B | |||
| Open | High | Low | Value | Volume |
| 98.0¢ | 98.5¢ | 95.5¢ | $6.248M | 6.438M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 10000 | 96.5¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 97.0¢ | 116040 | 7 |
View Market Depth
| Last trade - 16.10pm 26/06/2024 (20 minute delay) ? |
| MSB (ASX) Chart |