"As the next step, the EMA encouraged the Company to submit its Paediatric Investigational Plan (PIP) to the EMA Paediatric Committee (PDCO). The PIP is legally binding and addresses the entire paediatric development program (including use in patients up to and including 18 years of age). The Company is well advanced in its planning to submit the PIP. The Company will look to address EMA Scientific Advice recommendations and confirm the Phase IIb trial design through its PIP application to be submitted in Q4’20. Initial PDCO feedback is to be received ahead of submitting the Phase IIb trial application."
Still a bit of work to do before we get the green light!
.
Ann: EMA DMD Scientific Advice and Regulatory Process Update, page-3
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Last
7.7¢ |
Change
0.000(0.00%) |
Mkt cap ! $69.41M | |||
| Open | High | Low | Value | Volume |
| 7.7¢ | 7.9¢ | 7.6¢ | $148.9K | 1.895M |
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| No. | Vol. | Price($) |
|---|---|---|
| 1 | 48919 | 7.7¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 7.9¢ | 70000 | 1 |
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| Last trade - 15.59pm 03/05/2024 (20 minute delay) ? |
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Last
7.8¢ |
Change
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| Open | High | Low | Volume | ||
| 7.7¢ | 7.9¢ | 7.7¢ | 43057 | ||
| Last updated 13.04pm 03/05/2024 ? | |||||
| PER (ASX) Chart |