Earlier today, ahead of a panel meeting about Durolane scheduled for Wednesday, the FDA presented materials saying that Q-Med's studies do not show any statistical difference between Durolane and a saline control product.
In the published document, the FDA said that Durolane is generally safe, which is the most important factor in this case as the product is not a medicine, two unnamed analysts told Nyhetsbyran SIX.
Therefore they expect the product to get approval soon.
Another analyst still estimates that there is a 50/50 chance of Durolane being approved.
If the decision is positive, Q-Med will get a milestone payment of USD30m from its UK partner Smith & Nephew plc (LON: SN).
However, if it is negative, the estimates for the sales of the Swedish company will be downgraded by 2%, according to the analyst.
(EUR1 = USD1.4)
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