sounds like you may have been brainwashed into falsely believing that mesoblast continues to blatantly ignore fda recommendations for another trial.
if you check back over the announcments, fda has not requested an additional trial. they have requested more data. they are not asking for more proof of efficacy in more patients.
they had also guided msb not to initiate any further trials until outstanding cmc issues have been adressed.
when you say that need was "negotiated away", i think you mean. they are confident they now have the data including an assay that was standardised to show the registrational trial was adequate and well controlled. and that the critical product charactertics from the trial match the intended commercial product..
they would only need another trial if they don’t have this data and they've now said they have what they think is needed.
sounds like you may have been brainwashed into falsely believing...
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.16 |
Change
0.070(6.45%) |
Mkt cap ! $1.318B | |||
| Open | High | Low | Value | Volume |
| $1.12 | $1.20 | $1.11 | $20.88M | 17.94M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 5 | 59978 | $1.15 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.16 | 34019 | 3 |
View Market Depth
| Last trade - 16.10pm 06/05/2024 (20 minute delay) ? |
|
|||||
|
Last
$1.15 |
Change
0.070 ( 5.63 %) |
||||
| Open | High | Low | Volume | ||
| $1.12 | $1.20 | $1.12 | 3733217 | ||
| Last updated 15.59pm 06/05/2024 ? | |||||
| MSB (ASX) Chart |