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Re: mtoronto post# 169986

Friday, 01/25/2019 2:52:26 PM

Friday, January 25, 2019 2:52:26 PM

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https://www.fool.com/knowledge-center/what-is-a-fda-complete-response-letter.aspx

Dynavax announced the receipt of a complete response letter for a new hepatitis B vaccine in 2016, its stock tanked in response to the company's disclosure the letter asked for clarification of safety data observed during studies leading to its approval.

In 2016 the number of complete response letters issued spiked to a three-year high, largely due to increased concerns related to manufacturing facilities.
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