Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

Yes, but its still the same old Sunil. Every answer raises a dozen questions.

The article states: “Although Titan’s flagship product is its Probuphine implant, it is also working on implants to treat chronic conditions such as Parkinson’s disease and hypothyroidism. Bhonsle told us that the team expects to hear from the FDA in the next couple of months regarding an Investigational New Drug Application for its Parkinson’s implant.”

But 21 CFR Section 312.30 states:

“(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.”

It only takes 30 days for the FDA to respond to an IND filing. So is Sunil saying, because they don’t expect to hear from the FDA for a couple of months, that the IND hasn’t been filed yet? The original target for filing was in 2015. Then 1H 2016. Then 2H 2016. Then "early January" 2017. And...