Replies to post #12571 on Titan Pharmaceuticals Inc (TTNP)

[Serenity3]

Turks, I don't know about timeline .. Doc is probably more adept @ answering .. the only thing I would say is improbable is Braeburn being involved as they strike me as having no depth in clinical understanding of this field.. they've rolled out their products by using the OLD & INEFFECTIVE formula in their marketing .. train the docs, buy them & their staff lunch = sales w/out understanding the end users, the competitors, the regulatory environment or the legal and political field.. but then again.. TTNP picked them in the first place, so who knows

[Doctor Detroit]

Well, its an approved drug, so they are using 505(2)(b). We don't have any visibility on how far along they are into the clinic with perfecting the formulation and animal testing, etc., so it's impossible to say when they might be ready to file an IND application.

Once in clinical trials, I assume they will go for a Phase 1/2 combined study. I don't know anything about Vivitrol...are their multiple dosages? The scope of the Phase 1/2 will depend on how many dosages are being tested (e.g., ropinirole is taking longer because four separate dosages are being tested).

If the Phase 1/2 is successful, I assume it will be outlicensed at that point.

If not, need at least one Phase III efficacy and one Phase III safety study.

If they are fast, they could get it done in three years or less.