Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

While we sit in a holding pattern, I’ve been trying to determine whether there is any objective evidence of whether a PDUFA extension is an indicator for how the FDA will eventually act. With the caveat that (a) this is two years old and (b) I have no idea whether this information is correct, I found some comfort in the following statement by Roth Capital commenting on another company's PDUFA extension:

“19 companies have received PDUFA date extensions in the last 1.5 years, and 16 of 19 went on to receive drug approvals. Of the remaining 3 companies, 2 did not receive approval due to manufacturing site issues.”

My understanding is that the FDA has toured and cleared the manufacturing facility that makes the probuphine rods, and so if you exclude the two results where approval was not received due to manufacturing site facilities, that means 16 of 17 PDUFA extensions led to drug approval, or about 94.1%.

http://www.streetinsider.com/Analyst+Comments/Roth+Keeps+Keryx+Biopharma+(KERX)+at+Buy+on+PDUFA+Update%3B+Extension+Preferred+to+CRL/9519317.html