Скачать или смотреть FDA PDUFA Catalysts NOVEMBER 2021

FDA PDUFA Catalysts NOVEMBER 2021


This overview covers companies with a market capitalisation of up to 10 billion (more or less), as the run-up tends to work better with smaller biotech companies.



RISKS
MANY BIOTECH COMPANIES ARE STILL IN DEVELOPMENT STAGE AND INCUR LOSSES. THEY ARE SUBJECT TO A NUMBER OF RISKS, including, but not limited to, the lack of available capital. Those companys may take advantage of a run-up in order to raise capital by issuing new shares at an offer price below the market price, which may adversely affect the stock price.
Before the actual PDUFA, the FDA may announce an Advisory Committee Meeting (Adcom) to get an independent opinion by a panel of experts on the drug. Even though the FDA does not have to follow the Adcom’s opinion, if the Adcom votes against the approval of the drug in question, it may adversely affect the stock price of the drugs’ sponsor.


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