Take another read of the comments made by the chairman of the adcom committee.He clearly says that "WE" have a short time to get them completed.Is we theFDA and Titan.This is a lock to get approved with or without a slight delay.
Just my guess, but I'm wondering if the REM's issue has to do with the possibility that the rods have a residual amount of controlled substance in them after 6 months that someone would have to document the aquiring, and destruction of, or transfer of used rods to an authorized party for destruction. This is the only product I can think of where the office actually could or would get back the remains of a controlled substance. I suspect the ownership of the rods needs to be spelled out. Are they property of the patient to be returned at their discretion with the physicians office responsible for handling disposal or transfer to a party actually disposing the used rods? Or are the rods the property of Titan/Braeburn or the Physician's office and which of those partys is responsible for keeping return records and disposing the used rods? This is the kind of thing the DEA thinks about.
Solving this "problem" is not really a rocket science, but between the lawyers and the DEA they might try to make it look that way. Still the issue of disposal of alludes to a different angle about what could be one of Probuphine's bigger advantages, that is that when therapy is done using a set of rods and they are taken out, the physician's office could be the place to leave them. This is a really big deal because most teens get their first taste of opiates straight from a friend or family's medicine cabinet and frequently it is from prescriptions long discontinued or forgotten and never disposed of.......and THAT makes a great reason to seek Probuphine use for pain relief.
Once again, the REMS that was discussed during the AdCom was not the revised one which had already been submitted to the FDA prior to the day of the AdCom. The central REMS issue had to be deferred to the DEA by the FDA, since the latter had no jurisdictional authority over the issue. We have no access to information which would absolutely render an informed decision on this however; once again, from the audience it appeared to me that the confidence level was "high" on the Titan/Braeburn team, as a very slight smile was on Kate's face when they began to discuss that "issue" initially. This indicated to me it was already perceived to be a "non-issue" by the team. Some mistaken anxiety may have been perceived by onlookers shortly thereafter, as other unrelated study data (superfluous though it was) was called for but not available at that time. That too was but a diversion in my opinion, one of many the goofy panelist Dr. who brought up "reimbursement" issues (which have nothing to do either with the FDA or the NDA) as a segue to establish his shaky platform stance on "surgical procedural" concerns (laughable when considering a little "boo boo" as compared to the internal injury of addiction, or the external injuries that exist with needle-dependent junkies, just for two examples). I know I've shared this multiple times before but my take was that a lot of the "challenge" stuff coming from the panel was either irrelevant in context to the FDA's mission, became tangential yet handled sufficiently to have been supported by a majority positive ballot, or were simple attempts to be "included on the record," thereby officially justifying their presence at the meeting. No one can say conclusively at this point that the REMS is satisfactory to the FDA. Usually, one’s initial take is the most accurate one. I admit I came away a bit uncertain too but after discussing it with another poster here whose opinion I respect, concluded things with the REMS were alright.
Slight delay may be a month or 3, based on how FDA treats newly submitted information. Thing is, you would think that the FDA already knows how it wants the REMS to read, so it shouldn't take that long. They might as well have written the REMS themselves and just give it to TTNP for signing.
I'm fairly certain it is the DEA who sets most of the REMS requirements for these drugs.
Titan has talked to them and submitted a new REMS that the DEA has hopefully approved. The only thing the FDA can control is the training for the procedure and they've already approved training for similar procedures that is not nearly as extensive as Titan's.