Having failed to convince the European Medicines Agency yet again that its sickle cell disease drug, Xyndari, merits pan-EU approval, Emmaus Life Sciences believes it might have more luck by using one of Europe’s regulatory procedures that does not involve the EMA. For its part, the EMA says the company will need new data if it is to succeed.
Emmaus: ‘We Might Stand A Better Chance In Europe Without The EMA’
The company will need new data if it uses the decentralized route For Xyndari
Emmaus Life Sciences is dusting itself off following the rejection by the European Medicines Agency of the company’s sickle cell disease drug, Xyndari. The company tells the Pink Sheet that it might have better luck in Europe on a country-by-country basis in member states where experts have shown support for its product and where there are many patients with the condition. Not surprisingly, the EMA has defended the system it follows.
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