Titan Pharmaceuticals Is Back in Play With FDA Questions Resolved

| About: Titan Pharmaceuticals, (TTNP)

It didn't take too long to see shares of Titan Pharmaceuticals (NASDAQ:TTNP) rebound to near the two dollar mark again after a report of a delay in the examination of data from the Probuphine Phase III trial hit the wires a couple of weeks ago.

At the time, the request from the FDA that Titan alter the already-agreed-upon Statistical Analysis Plan (SAP) sent shares tumbling to as low as $1.30, given the newfound uncertainty surrounding what had otherwise been a stable investment on the year.

Last week, however, Titan issued a release that should put an end to the uncertainty. According to Thursday's announcement,

Based upon its ongoing dialogue with the FDA and to maintain the trial's clinical integrity, Titan will conduct primary efficacy analyses comparing the Probuphine and placebo arms using the trial's protocol-specified primary endpoint of the cumulative distribution function of the percent negative urine samples, as well as an additional analysis of this urine toxicology that will incorporate patients' self-reports of illicit opioid use, as requested by the FDA.

It looks like the FDA just wanted to make sure that the patients who claimed to have been using opioids illicitly were telling the truth in regards to those claims. The release read further:

This additional analysis comparing the Probuphine and placebo arms incorporates patients' self-reported data to ensure that within the assessment time period, the number of positive urine test results correspond to at least the number of days of opioid use reported by the patient.

Not much of an unfair request from the FDA, and far from a worst-case-scenario that would have sent shares plunging again. Investors can now look ahead towards the unblinding and statistical analysis of the data for the trial, which is now on slate to be released later this month.

The dip on the uncertainty may have offered a decent buying opportunity leading into the announcement of these results, as the majority of the quick losses have already been regained, and it's likely that Titan might inch back up towards the two dollar mark before the results are released.

With another quarter under the belt, the compay should also expect to shortly receive news on how well Vanda Pharmaceuticals' (NASDAQ:VNDA) Fanapt did on the market during the past three months. Through a licensing deal with Vanda and its Fanapt-partner Novartis (NYSE:NVS), Titan receives an 8% royalty on sales of the schizophrenia drug, which has been increasingly gaining market steam over the past few quarters.

This is a cost-free revenue stream for Titan, providing revenue stability. Most company resources are being directed towards bringing Probuphine to market as a treatment for opioid addiction and chronic pain.

With the FDA uncertainty surrounding the SAP now in the rear view mirror, Titan once again looks like a solid pick moving forward. The Probuphine results are expected in a few weeks. Should they turn out positive, then talk of a potential partner or buyout might start to surface, making Titan an exciting play for the remainder of 2011.

Stay tuned for developments.

Disclosure: I am long TTNP.