This morning shares of Opko Health (OPK) fell hard in pre-market trading. The company received an FDA notice that it will not receive approval for its drug, Rayaldee.  What’s important here is that the denial was not directly related to Opko, but to the company that will manufacture the drug.  The third party manufacturer has said that it will respond to the FDA’s recommendations immediately.

The company issued a press release that includes three key bullet points:

• Sole issue relates to third-party manufacturing observations
• No new clinical studies requested
• No safety or efficacy issues identified

Here is what to do:

1) Keep the sell stop at $9

2) Watch for the market’s response to the call

3) If prices stabilize above $9 aggressive investors should consider adding to positions

We’ll continue to monitor the situation and report accordingly.