This expanded multi task FDA approval is a major high point for RHT , I wonder what this FDA approval will do for the share price and income it will generate from the USA alone ? RHT has a market cap of only $10.46 million , from today , this is a different ball game, Well Done.
The FDA 510(k) clearance for FerriSmart® is in addition to regulatory clearance obtained in July 2018 from the TGA - Therapeutic Goods Administration (Australia), and CE Mark (European Union) (ASX announcement dated 11 July 2018).
The FDA has cleared FerriSmart® with the following indications:
- Measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;
- Monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions; and
- Aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
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Ann: FDA Clearance Granted for FerriSmart, page-3
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1 | 10000 | 0.043 |
2 | 230000 | 0.042 |
1 | 300000 | 0.041 |
4 | 501337 | 0.040 |
Price($) | Vol. | No. |
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0.049 | 100000 | 1 |
0.050 | 60084 | 2 |
0.059 | 15764 | 1 |
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0.065 | 55000 | 2 |
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