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SEC warns pharma companies to be honest about FDA correspondence
(see also the full comments from SEC official Andrew Ceresney, highlights of which are below)
"Now financial reporting is not just about financials. It is also about disclosure, which is the next topic I want to address. The goal of course must be accuracy and timeliness in sharing material information about your company. This includes appropriate disclosure of key events, which are often disclosed on an SEC Form 8-K.
One significant type of key event that we see causing problems with disclosure in your industry is disclosures on your dealings with the FDA. Accuracy of reporting in your dealings with the FDA is critical to getting investors the information they need. FDA dealings and approvals are the lifeblood of your business and are so important to investment decisions. And our cases, some of which relate to failures in this area, reflect this." ...
"The message from these cases is that you need to be completely accurate in recounting your dealings with the FDA. So much turns on those interactions and not being straight with investors will have significant consequences." ...
"As you can see, sharing the FDA correspondence with investors eliminates many of the issues we have discussed because investors get to see the actual back and forth and judge for themselves. This obviously isn’t practical for every item of FDA correspondence, but it is important to consider such disclosure for critical ones."