On Monday, Clinuvel Pharmaceuticals Ltd’s share prices have been one of the worst performers on the domestic share market. In the morning trade, the shares of the Pharmaceutical company dropped as 11.5 percent to $30.5.
What was the major reason behind the downwards crash of Clinuvel’s share today?
Investors were pretty fast to hit the sell button this morning after Clinuvel gave the provision of an update on the Prescription Drug User Fee Act date for the goal of its product ‘SCENESSE’.
According to the release, the United States Food and Drug Administration Division of Dermatology and Dental Products has set an updated Prescription Drug User Fee Act goal date of 6th October 2019.
In actuality, the Food and Drug Administration had set the goal of 8th July but then extended it by 3 months in order to provide it with additional time for a complete review of the submission of the SCENESSE medical dossier.
Investors may have been disappointed because this had let to the delay of their potential sales of its major compound in the profitable markets by an extra three months.
The Chief Scientific Officer of the company, Doctor Dennis Wright, apparently seemed to be dissatisfied with the delay.
He passed the following statement: “This is not something new that the Food and drug administration have extended its own timeline when it finds the need to take more time for the reviewing and to reach the final benefit-risk assessment. However, it is very frustrating that while our product is being recommended and prescribed to the patients in Switzerland and the European Union and some of the patients even travel all the way to Europe to get the treatment, most of the United States patients have just no access at to it.”