Tuesday, February 21, 2017 4:50:47 PM
Craig Wheeler
Sure, Dana. Thanks. This is Craig. I can’t really provide a lot of color on the nature of the deficiencies at this time, since we’re under confidentiality, and those observations were not on our product. So, they’re just general observations. However, that redacted letter should be available, maybe even starting today at the FDA. And once it’s public, we can talk more about it, but until that point in time, we’re under confidentiality with Pfizer. But, you should be able to get clarity on that soon, just directly from the FDA.
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