"In its September 2023 draft guidance to industry for development of agents to treat aGVHD, the FDA stated that a marketing application in a population with refractory aGVHD where there are no approved therapies might be supported by positive results from a single-arm trial"
I'm beginning to wonder if they have yet to discuss the trial design with the FDA if this is the justification they are giving.
"might be supported" vs "recommended pathway" previously advised by the FDA?
"In its September 2023 draft guidance to industry for...
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Last
$1.07 |
Change
0.020(1.91%) |
Mkt cap ! $1.216B | |||
| Open | High | Low | Value | Volume |
| $1.04 | $1.07 | $1.04 | $4.010M | 3.797M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 67587 | $1.07 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.07 | 45960 | 7 |
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| Last trade - 16.10pm 14/05/2024 (20 minute delay) ? |
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Last
$1.07 |
Change
0.020 ( 2.55 %) |
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| Open | High | Low | Volume | ||
| $1.04 | $1.07 | $1.04 | 699949 | ||
| Last updated 15.59pm 14/05/2024 ? | |||||
| MSB (ASX) Chart |