It serves purposes for other investors on here, who sometimes understandably forget exactly where we stand with the FDA, amidst some of the misleading crap that populates these theads. The company's advised timelines are useful to immediately have to hand.
Essentially OTAT meetings on potency in Q4 that will drive both the BLA application in GVHD and an EUA and phase III trial in COVID-19 (and possibly Novartis signing off) and continued feedback from the FDA in Q4 from recent CHF and CLBP meetings. These are not unhelpful timelines to reiterate.
The company has actually been pretty good lately in holding to guided FDA schedules and giving feedback.
Regulatory Pathways - where we stand with the FDA, page-74
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Last
$1.11 |
Change
0.010(0.91%) |
Mkt cap ! $1.261B | |||
| Open | High | Low | Value | Volume |
| $1.09 | $1.11 | $1.07 | $4.794M | 4.399M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 2 | 14500 | $1.10 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.11 | 141676 | 5 |
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| Last trade - 16.10pm 11/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |