So, i'm curious what the bear case against approval is?
We can argue about sales potential all we want, but we have solid scientific data that can be analyzed to either support or deny approval. Can anyone make a case for them denying Probuphine (manufacturing issues don't count...that's another "what if" scenario)?
Nowak, I think another big bear case that has not yet been mentioned, although it does somewhat qualify as a "what-if" scenario, is that many MDs are not willing to learn/implement the procedure. I have spoken with a few suboxone prescribers in recent months and asked them/told them about the implant. There is mention of liability if the implant goes wrong, questions of practicality (why this over suboxone), and these MDs are making tremendous money by keeping addicts perpetually on Suboxone. So to summarize, the product may be revolutionary, but many MDs may not even consider it when they are cashing on in on opiate addication. ***Hopefully, we will see big support from the patients themselves insisting on the implant after years of failed suboxone treatment***. I welcome any feedback or additional opinion.
That's a question of commercial success, not a question of whether the FDA will find the product safe to approve.
We can talk about it though. If doctors make money off of Suboxone, how would they not make money off of Probuphine? It is the same treatment (different method) for the same patient group AND it involves a special procedure that they can charge extra for. There is also the probability that the 100 patient limit won't be there for Probuphine.
Outside of that, there is no real liability. If the doctor can take blood, or give a shot, then they can do the implanting. If they can stitch someone up, they can do the removal.
Google "Implanon Insertion and removal" and you'll see just how hard it is.
By the way, there are millions of Implanon procedures performed each year. It is the exact same thing as Probuphine and it is still a 400 million dollar drug (MUCH cheaper than Probuphine and it lasts for 3 years...the market is much larger than the 400 million dollar number may lead you to believe).
Staylon, yes Suboxone does have titration dosages from 4mg to 24mg per day.
It varies with each patient and a doctor will decide necessary dosage.
There are 3 protocol stages to suboxone use and the final maintenence is at a lower dose,
Probuphine would probably at first be used somewhere between the 2nd or 3rd line maintenence after the intial use of Suboxone is first introduced to the patient.
Probuphine becoming gold standard 'might be possible but a higher dosage of drug might be necessary to be added to implant.
Not sure, but maybe a future trial at a higher dose might be needed to have chance at gold standard first line treatment. for opiod dependence .
Depends how clinicians view the current efficacy of drug as a replacement for suboxone or as an adjunct with suboxone.
Manufacturing is not the main issue for an adcom. That could come later. Adcom may actually indicate that everything so far seems fine with CMCs, or else they wouldn't be wasting the time of the experts
Because it is pointless to speculate about something that we have no idea about.
The unknown is always the greatest risk, but they have people in place to handle it.
Plus, I am aware of certain events that indicate that they are on top on manufacturing. It may be an issue, but I'm confident it won't be.
Lovie it is not "Jodie". The name is "Andy". Read the handle. He is "Jodie('s) Andy". He is Andy who belongs to Jodie. And obviously is proud of it.
What about your soup theory as a Bare Case? Or how about abuse by children using the inserts as Frankenstein eyelids during Halloween? They could become addicted through such abuse. Lots of problems with the rods, eh?
Jon asked for bear opinions and that's what I wrote I wrote. The difference Fiddy Cent, is that I strongly believe Probuphine will not only be approved but will also be commercialized successfully. As with any important process, the steps to market are not always easy and in this business, rightly so. Any way it goes, I believe Probuphine will succeed but I'm far from certain all the drama surrounding it is even close to over.....again, just my opinion. I also believe they SP here is way undervalued even now AND that there is a strong chance for a lower entry point for new investors, or for current holders to average down before it's over. I state this on past history since the AdCom, like every other news event about Titan and especially those positive, will have a contrarian effect on SP. All this flagrant price manipulation on the OTC can have a profitable effect on investors who've been paying attention and unlike "supposed" short investors like you, it isn't necessary to bet against the company in order to accomplish that. Just the past few weeks we've seen 2.50 plus down to the 1.80s. That's a WIDE swing and knowing it's going to return to 2.50 and more isn't rocket science, especially to those who've been paying attention for years. You don't have to be a genius to see how much money has been made by small retail investors throughout the past 4 years alone, swing trading their small positions at the tiny online brokerages. So keep singing your song there Fiddy Cent. Likely someday you'll win a "SCAMMY"as best new financial failure in the troll category.
I believe approval is certain, however I'm not so sure it will happen first NDA or by 4/30. As requested, other than manufacturing issues, my first concern is the Phase IIIb data clarification they did by FDA request July 2011. Second there's the size of the studies themselves. In a population that small statistical sampling could easily be skewed to support any argument, certainly enough to indicate less than substantial equivalence to existing treatments. Finally and although I know it sounds conspiratorial, I'm concerned about the commercial threat Probuphine poses to others in their business, specifically RB, and the known fact that on other panels there have been more than just a small number of conflicts of interest or other unfair biases among panel members. The FDA relies upon the opinions of "experts" knowledgeable about the science being considered. It's sometimes difficult to say the least to find "experts" who don't have some inherent bias. Admittedly, that could go the other way as well and again, perhaps I'm just borrowing trouble, but I've seen it happen (DNDN is a prime example). Having said these things, I still feel strongly Probuphine will be approved. I say this not just from a belief in the science or some well placed confidence in Titan or AppleTree's business acumen, but because public and political pressures dictate policy and the FDA "IS" that policy. If they were to bow away or resist it would be the first time to my specific knowledge that they've done so successfully. They'll let this, as they've done so many similar politically charged policy driven chemicals, go to market. Then they'll either allow it to remain there until it crucifies itself and the business behind it or the general public outcry against it gives them grounds for its withdrawal from market.......just my opinion BUT I'm still here after four years and will remain for the end. I'll be in the audience in Bethesda 3/21 since I'm in DC that week anyway.
Wow, really. Been reading this entire list of BS; This is about a delivery system with a drug already approved. That’s it. How much testing does it take to determine if the dosage overtime is delivered correctly and that the delivery system is non-toxic? That’s about it folks. It’s done. No drama...
I am now leary of any adcom after Dynavax crashed in an unexpected panel vote and I lost a lot of money. The briefing docs were positive and the FDA worked with Dynavax to expand the label only to be screwed by one particular adcom member. Still long Titan.
Sentiment: Strong Buy
Also, the FDA gave them guidelines for the size they wanted to see. They weren't very large and Titan pretty much meets all of the requirements that the FDA asked for (they are a few people short for some of the requirements). This was all done when the FDA knew little about Suboxone and the 505(b)(2) pathway was not in the picture.
Of course, this is a valid point, but I'm confident that the company has its bases covered on this one.
Once bio-equivalency is established, the 505(b)(2) application pathway allows Titan to use other published data to support the NDA.
They granted 505b2 status. We don't really need to show efficacy, just safety.
a very simple subcutaneous (just under the skin) implant could easily be gouged/cut out if one wanted to crush the polymer rod and inject that. Sadly, this is conceivable, since it is just buprenorphine and no full antagonist. Please comment with thoughts.
I don't pretend to know, but am only thinking out loud about your question. In the treatment process using the pill, are gradual dosage reductions made with patients within a six-month timeframe? If so, can Probuphine accomodate that scneario? Just a thought???? GLTA!
Best bear case to me is the fact that these are implants and you need 4-5 of them. Implants, if not done right, can cause discomfort, injury and even lead to lawsuits and product recalls. Many years ago, a company called Wyeth, I believe, sold a birth control implant called Norplant. Many thought it would do well but there were some issues with getting it in and out which led to plaintiff lawsuits against the drugmaker who said the hell with it and pulled the product. We live in a litiguous society and we encourage class action lawsuits and in the process, good brands can be destroyed. Having said that, this is a very special drug for a very special population whose needs and society's needs are uniquely well served by this product so I am very long but do recognize the difficulties. In addition, throughput in the surgery will determine drug sales and I am not sure what kind of bandwidth is achieveable.
A lawsuit for discomfort?
Isn't there discomfort and pain anytime you go for surgery? Are the surgeons sued for discomfort?
Isn't there discomfort during minor dental procedures? Are dentists sued for discomfort?
The possible side effects of the implant procedure will be specified.....possible bruising, swelling, discomfort. Any lawsuit for discomfort would be frivolous.
Norplant still marketed world wide ..." Wyeth never lost a Norplant lawsuit, even in cases which came before a jury.... Norplant and other implantable contraceptives are especially effective in the developing world, as they do not require daily administration or access to a hospital to be effective. In addition, no continual contraceptive supplies (pills, condoms, etc.) are necessary, and it is a highly effective, low cost contraceptive over the long term.".. quotes form Wikipedia on Norplant history... good read
My question too!
I can't seem to find any negatives out there which would discourage all ADCOM members from voting 100% for approval. Here are a few positives to re-iterate:
1) you don’t have to worry about taking a medication every day
2) you don’t have to experience the nasty Suboxone orange flavor every day
3) you don’t have to worry about your medication being lost, stolen or sold
4) if you go to jail or rehab for a while during the time the implant is working, you won’t experience an interruption in medication (or go into withdrawal)
Sentiment: Strong Buy
I think the Bear case would be limited to the size of the sample. But,litigants never have trouble finding medical experts for either side. A competitor could hire experts to wax eloquent on the issue Dr. Ling has raised: subsidizing the treatment of addiction with buprenorphine.
Personally unless there's a corrupt panel I don't see such arguments being persuasive. The FDA is well aware of the problem of diversion of RX opiates which are zero resistant to tampering. All of the activity of late before the FDA concerning placing prescription drugs on a more restrictive schedule to limit access to pill forms leads me to believe that a slight chance or removal of the implant by the most desperate addicts would be an insufficient reason not to make it available. The evidence from the trials is that a very high perecentage of those who completed the 6 month study signed up for the 12 month study.