Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

I think they can always extend a PDUFA date (I believe its just a goal, not a requirement). This is all conjecture on my part, but if I'm right:

1. Both the FDA and Braeburn/Titan agree that probuphine can be prescribed to patients needing 8mg or less of buprenorphine and that the product labeling could include claims about preventing diversion, accidental pediatric exposure, etc. If the labeling had a "black box" saying probuphine could only be used for 8mg or less, I think it would be approved by now. Still a pretty good market, but not the one that Braeburn wants.

2. The FDA either: (a) wants the labeling for probuphine to strictly state it is only intended for patients needing 8mg or less (i.e., #1 above), or (b) wants the labeling not to include claims about preventing diversion, accidental exposure etc. because its contemplated that probuphine will be used in connection with pills that carry the risk of diversion, accidental exposure.

3. Braeburn may be sticking to their guns and saying: "We have an effective, non-inferior and safe way of administering 8mg of buprenorphine that deserves to be approved on that basis alone. We don't agree to labeling that limits the patient class to those requiring 8mg or less, because sublingual buprenorphine is readily available for those requiring more. And we should be able to make all the non-diversion, accidental exposure claims that are inherent with our product. The fact that our product may be used in connection with other products that have those risks doesn't make our product, in and ofi itself, any less safe or abuse deterrent."

Not sure how it would ultimately play out. Braeburn has pressures to get probuphine to market, but it may be worth "playing chicken" with the FDA by not agreeing to bad labeling. Worst case they probably get an "approvable" rejection letter (saying it would be approved with the appropriate labeling), and they could then appeal the decision. They have logic on their side, and the last thing the FDA wants is a bunch of bad press.

Personally, I think labeling that restricts prescriptions to those needing 8mg or less is just wrong and worth fighting over because of the huge market that would be lost. If the question is just whether you can make non-diversion or accidental exposure claims in marketing materials, then it becomes a tougher decision whether to fight it.