Legit, I hope MSB gets the approval this time.
Maybe the FDA has changed its mind and decided it was purely the potency assay that was the issue. CRL wanted potency assay data - they did not change their mind.
The reason I'm skeptical is because less than a year ago, when the second CRL was issued, MSB said it would address the issues raised by performing another trial in adults in order to gather more evidence. Or come up with data that answered the CRL
That has slowly morphed into just needing a potency assay. Without management explicitly saying that the FDA only requires this Incorrect- in fact the company was explicit in detailing the requirements of the FDA, also stating that efficacy was not an issue- repeat- efficacy is accepted by the FDA
After the first CRL, MSB said the FDA requested a further RCT for more evidence. Yes- in either kids or adults OR provide potency assay data in place during the 001 trial that can prove potency of todays stock on the shelf.
That then morphed into drudging through post hoc analysis, etc, and they reapplied a second time, and everyone was certain it would be enough. No - that morphed into several months of correlating data that had not been presented to the FDA- data from the 001 clinical trial
Including Si.
I hope I'm wrong this time. I've highlighted in purple your descriptions that negate your wish for a positive outcome
Hey Doc - now that manufacturing, safety, efficacy are ticked off and the FDA have just liked the look of the new potency assay data- are you still a sell?
- Forums
- ASX - By Stock
- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
Legit, I hope MSB gets the approval this time.Maybe the FDA has...
-
- There are more pages in this discussion • 831 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
|
|||||
Last
95.0¢ |
Change
-0.020(2.06%) |
Mkt cap ! $1.090B |
Open | High | Low | Value | Volume |
98.0¢ | 98.5¢ | 95.0¢ | $1.458M | 1.518M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
41 | 165128 | 95.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
95.5¢ | 98112 | 28 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
41 | 164846 | 0.950 |
16 | 163715 | 0.945 |
15 | 295327 | 0.940 |
6 | 413419 | 0.935 |
7 | 113828 | 0.930 |
Price($) | Vol. | No. |
---|---|---|
0.955 | 98112 | 28 |
0.960 | 131825 | 19 |
0.965 | 101635 | 11 |
0.970 | 95138 | 8 |
0.975 | 112835 | 3 |
Last trade - 14.36pm 06/09/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |