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There is no cap on royalty payments. The amount of milestone payments (in addition to royalties upon achieving sales targets) is $165 million. There are also $35 million in regulatory milestones payable upon submitting NDA's and NDA approval for other indications (e.g., chronic pain).
Yeah, I don't think you just submit a supply contract in the absence of a request by a government agency...often, the agency issues a request for proposals so you get competitive bidding, but as there is no other supplier I don't think they would have to jump through that hoop.
Nice to finally have some numbers.
...time will tell. Product available starting the 13th, so it will be interesting to see how quickly the first implantation procedures follow. Only three insurers are currently allowing coverage, but I'm sure there will be more to follow.
When awarded, it would post on the FBO.gov site. Since there is only one source for implants, they wouldn't have to bid it out. See example of recent $44 million award for pills to VA.
https://www.fbo.gov/index?s=opportunity&mode=form&id=60191ff2e08c692fb57fcc664414f7d8&tab=core&_cview=1
Braeburn Presentation
I went through it in detail last night, and it convinces me I am correct to ignore the stock price for the next few months. Traders are going to trade, and shorters are going to short, so let them. I'm happy.
In the June 7th Jefferies presentation, Braeburn has gone on record in writing to the world that:
1. There are currently 825,000 patients in the US taking buprenorphine (from presentation).
2. 47% of those patients have stabilized at 8mg or less (from PDAC meeting). That means 387,000 people are on 8mg or less.
3. At page 30 of the Presentation, Braeburn is estimating a 15.7% market share based on interviews with 150 buprenorphine prescribing physicians.
Applying those numbers....
1. 15.7% of 387,000 = 58,100.
2. 58,100 x $4,950 (price) x 2 (treatment cycles) = 575 million
3. Chronic pain market, long term, is just as large according to the Braeburn presentation. So double sales to 1.150 billion.
4. #'s above excludes the effect of doubling patient prescription limits and ROW sales.
Turks, I think #5 is a long-term contract for use with federal agencies. The means to accomplish Veteran's Administration or Bureau of Prisons sales.
All Federal Supply Schedule contracts are multiple award, indefinite delivery-indefinite quantity type, and are national in scope. These contracts are available for use by all Government agencies including but not limited to: VA Medical Centers, Department of Defense, Bureau of Prisons, Indian Health Services, Public Health Services, some State Veterans Homes, etc.
http://www.fedgovcontracts.com/chap13.pdf
http://www.fss.va.gov/
Thanks Truth! A must read.
1. Still projecting 2H 2018 launch for probuphine for chronic pain (page 6).
2. Probuphine will be available to health care providers for use on JUNE 13th. Next week could be the first commercial implant! 500 health care providers have already been trained (page 7).
3. Plan to train 3,670 health care providers by November (page 9).
4. 3 insurers have allowed probuphine coverage since May 31st. CareSource, Highmark BCBS and BCBS of MA #38 $08.4 M
5. Federal supply contract to be submitted by June 20th.
Interesting factoid from press releases: as of today (June 9th), 500 health care providers have been certified.
Positive article by Corvel...a risk management firm used by workers comp. and health insurance companies. They confuse probuphine with buprenorphine once or twice, but as they are recommending allowing coverage it's all good.
http://www.corvel.com/blog/articles/fda-approves-implant-for-opioid-dependence/
That would be huge! Sales of probuphine in the EU could begin right away. I think the Senate would have to ratify such a treaty...not sure the likelihood in an election year.
We especially commend HHS for recognizing that certain types of buprenorphine products should be treated differently under the buprenorphine patient limit because they inherently minimize the risk of diversion and ensure patient compliance. Braeburn’s comments in response
to Question 2 in the proposed rule will recommend that patients treated with buprenorphine drug products labeled for direct administration by highly-qualified addiction treatment providers should not count toward the DATA 2000 prescriber patient limit.
If they are successful and the Final Rule includes such an exemption, there would be in effect no limitation to probuphine prescriptions.
As I thought, Braeburn IS all over this. The link is to their 26 page commentary to the Department of Health and Human Services
https://www.regulations.gov/#!documentDetail;D=SAMHSA-2016-0001-0446
The means for accomplishing that goal is already built into the proposed rule (I'm sure Braeburn is all over this):
(2) Potential New Formulations—The Secretary shall establish a process by which patients who are treated with medications covered under 21 U.S.C. 823(g)(2)(C), and that have features that enhance safety or reduce diversion, as determined by the Secretary, may be counted differently toward the prescribing limit established in this proposed rule. The criteria for determining which if any of these medications or reformulations of existing medications may be considered, and how these patients will be counted toward the patient limit, will be based on the following principles:
a. Relative risk of diversion associated with medications that become covered under 21 U.S.C. 823(g)(2)(C) after the effective date of this proposed rule; and
b. Time required to monitor patient safety, assure medication compliance and effectiveness, and deliver or coordinate behavioral health services. HHS seeks comment on the principles by which the Secretary would determine which new medications would qualify.
https://www.federalregister.gov/articles/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disorders#h-61
Hopefully, the Senators' petition will do some good.
As a practical matter, I think there are enough votes in the Senate to get legislation increasing the limit to 500 passed, but it's a "no-go" as far as the House of Representatives is concerned. The ugly truth is that it won't pass because, by increasing the patient limitation, the cost of medicare/medicaid will increase. Of course, if the mandated treatment was probuphine then overall costs would probably decrease, but nobody gets elected to Congress by favoring just one company (even if it makes sense).
The Department of HHS is already in the process of adopting revised regulations that don't require Congressional approval (doubling the cap, etc.). The final regulations adopted could include a higher number (e.g., 500) for the patient cap, but I just don't think it will. Politics.
“Our staff doesn’t always get to see people get better,” Segal adds. “But in this study, it was very clear. This is really the first time our studies made such a huge difference in people’s lives.”
A nice thought to end a week I would like to forget as soon as possible!
Luckily, I don't think we have to rely on Titan's efforts at this point. An approved drug and a wide open market create the "chemistry" needed to bring this to a quick resolution.
Kate Beebe said three companies approached Titan to initiate due diligence on probuphine. So legal guys will look at the patents, sales guys will look at the market and medical guys will look at all the trial data. The three pharmas realize they are in competition with other companies for licensing rights. That's a good situation to be in. Back in the day I used to work on some pharma deals, and I know this process is not a real long one. It can be done as quickly as a month as long as Titan supplies all requested information on a timely basis.
Now, all three companies might look at the data and take a pass. But if someone is going to buy in I think it will happen by the end of Summer.
I get what you are saying, but remember Apple Tree Partners is a venture fund. They are looking for a huge return from the operations of their funded companies, not by their funded companies having investments in other companies. Eventually, they will want to exit their investment, either by Braeburn going public or by selling their interest in Braeburn. Sales and profitability drive valuation. You get a price based off a multiple of earnings. They don't give you a price based off a multiple of your invested capital.
Apple Tree doesn't want to fund Braeburn anymore than they have to in order for its to be successful. Even if Braeburn wanted to keep the stake in Titan, it's conceivable they asked for some draw down funding from Apple Tree, who said..."I see you have a bunch of Titan stock on your books, use that for part of your funding."
It's not helpful, that's for sure. But Braeburn is relatively small, and I I get them saying we are not an investment company, we are in business to sell develop and sell drugs. If they put the money towards a chronic pain trial, I'd be a lot happier...
The most important thing it tells us is that Braeburn isn't interested in acquiring Titan right now, or at least not at a price that Titan would agree to.
If they aren't going to acquire Titan, then it makes sense for them to liquidate. Their purchase of shares was more of "bridge financing" than an investment. The purpose was to assure Titan would avoid bankruptcy while waiting for the Phase III to finish and for the FDA to make its decision.
The purpose has been accomplished, and so it makes sense for them to liquidate. I don't see it as any backing off on the commitment to probuphine.
This is ridiculous. Quote from Fox News article:
Cidambi also questioned the removal process. She cited a simulation study in which doctors were required to remove all four rods, which had been placed in a model patient with different levels of difficulty. For example, one rod was glued, one was broken and one was implanted in such a way that the trainee would have to order imaging. Despite following proper procedure, only seven of 15 participating surgeons successfully removed all four rods.
Language from FDA Human Factors study:
On mitigating the risks resulting from complicated removal:
-7/15 participants succeeded in removing all 4 implants. The other 8
“followed proper safety protocol.”
-1 mid-level practitioner was unable to remove all 4 implants but
proceeded to close the incision. This participant indicated that it “would be prudent to close the incision, bandage up, and send the patient for imaging to return 2-3 weeks later).
-14/15 participants correctly requested imaging studies (ultrasound or MRI) to locate non-palpable implants prior to making an incision for removal. A mid-level practitioner failed to request imaging prior to making an incision despite indicating that imaging would have been warranted. She indicated that “she would have followed that guideline in a real patient situation.” The Applicant interpreted her response as “correct” due to “study artifact.”
An article in Psychology Today is one thing, but now national news...the fact that one single "addiction expert" has doubts...my gut tells me larger forces are at play. At least they had the courtesy to interview Braeburn as well...
Patients may also forget the drug is helping them achieve their sobriety, leaving them under the false impression that they don’t need to attend therapy or adjust their lifestyle changes. In turn, rather than addressing the problem, the device could lead to co-abuse and eventually relapse after the six-month period of Probuphine ends, Cidambi said.
However, Sheldon told FoxNews.com that the medication's labeling does idicate that behavior therapy is recommended, and that there is a policy in place regarding coverage for a patient that requires a physician to indicate that the patient has complied with recommendations for additional care.
http://www.foxnews.com/health/2016/06/02/addiction-expert-questions-recently-approved-anti-opioid-implant.html
Turks,
Thanks, my numbers were conservative on purpose...they are based on each certified doctor writing one prescription every two months. I think sales could be much higher, but even if they are not it shows how drastically undervalued Titan is at these price levels given the removal of the risk of a CRL. Although conservative, the numbers are an absolute out of ballpark homerun when compared with Roth and Zack's estimates.
You are absolutely right about probuphine changing people's lives. It will also change insurance companies. Braeburn's guaranty on cost savings won't be loss to insurers. De-tox, in-patient rehab, out-patient rehab, counseling, psychiatrist, sublingual medication, other medical expenses related to addiction, emergency room visits, ambulances...all drastically reduced by switching over to the implant.
...and I see we closed under $6 today. Screw the market. I know I'm right on this one.
Sales Forecast
Given Braeburn's stated goal of training 2,000 health care providers by mid-July, and 4,000 by year end, I have come up with the following estimate of the # of trained health care providers at the beginning of each month the remainder of this year:
July 1,200
Aug. 2,000
Sept. 2,400
Oct. 2,800
Nov 3,200
Dec. 3,600
If half of all those trained each month prescribe a singe (one) implant each month, the total number of implants prescribed in 2016 will be 7,600, for sales of $37.620 million @ $4,950 per implant. Royalty to Titan would be $6.4 million (about $5 million over Zack's estimate).
Carry that forward to the first half of 2017 with a static # of 4,000 health care providers trained. If only half of those trained prescribe only one implant per month you get $59.4 million in new sales. If 75% of those who had an implant in 2016 continue with a second implant, that's another $28.2 million in reoccurring sales. Total sales of $87.6 million with royalty to Titan of $15.3 million.
Truth, yes it's not just big pharma that is threatened by the implant. Rehab centers and counselors who, some have argued, make a living on continued relapses, could be threatened. And as for the doctor who wrote that article, who is based in New Jersey, Governor Christie has vowed to cut funding for substance abuse to hospitals that don't show results.
That could lead to a push towards allocating dollars to an implant over "Ambulatory Detoxification" as she called it.
https://tsnnews.com/christie-threatens-hospitals-to-improve-substance-abuse-treatment-programs/
Favorite quotation:
Now that FDA approval is official, drugmakers are also looking at expanded uses for probuphine, including its future potential as an opioid alternative for patients with chronic pain.
“We’ve had a lot of interest from clinicians who told us that they already use buprenorphine for pain in some instances,” says Sheldon, noting that the opioid alternative is far less addictive in many instances than traditional prescription painkillers. Braeburn aims to start talks with the FDA around probuphine’s use for chronic pain immediately, but the testing involved in pushing that next approval endeavor is likely to take a few years.
After a Long Wait, FDA Approves First Anti-Addiction Implant
https://www.poz.com/article/long-wait-fda-approves-first-antiaddiction-implant
Probuphine promises to deliver six months of continuous buprenorphine treatment. What does this mean for the future of the opioid epidemic?
June 1, 2016 By: Casey Halter
On Thursday, May 26, 2016, the U.S. Food and Drug Administration (FDA) approved probuphine, the first sub-dermal implant designed to help treat opioid addiction among adult heroin and prescription drug users.
The landmark device, developed by California-based biotech firm Titan Pharmaceuticals, and licensed for sale in North America by New Jersey-based Braeburn Pharmaceuticals, promises six months of continuous therapy with buprenorphine, currently the most widely-used medication-assisted therapy (MAT) option for treating opioid dependency in the United States.
In practice, probuphine consists of four small rods inserted by a licensed doctor under the skin of a person’s arm that deliver a continuous 4 mg to 8 mg dose of buprenorphine into the bloodstream. The device is one of the first truly novel treatments for opioid addiction approved by the FDA in nearly 14 years, and arrives as the United States is contending with an opioid addiction and overdose crisis that kills nearly 80 Americans every day.
“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA commissioner Robert M. Califf, MD, in the agency’s official announcement of its decision. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”
However, those familiar with addiction treatment know that the path to FDA approval for probuphine has been fraught with difficulties over the last few years. Federal health authorities originally rejected the device in 2013 due to concerns over its overall safety and efficacy.
The delay in probuphine’s debut to the American market raises a number of questions: Why approve the device now? What are its pros and cons for treating opioid dependency? And what does probuphine mean for the future of the anti-addiction industry?
The FDA’s official decision to approve probuphine in May comes just two months after its Psychopharmacologic Drugs Advisory Committee voted 12 to 5 in favor of approving the new technology. However, buprenorphine, the medication contained in the novel anti-addiction implant, has been approved and widely used by doctors to treat opioid addiction in the United States since 2002.
Today, about one quarter of the 2.8 million people estimated to have a diagnosed opioid abuse disorder in this country are prescribed buprenorphine to help them manage their addiction. Often sold under the brand names Suboxone and Subutex, or contained in other popular substance abuse treatments, such as naltrexone, buprenorphine works to suppress cravings and withdrawal symptoms in both heroin and prescription drug users, and helps to block the effects of other opioids. Until now, the anti-addiction drug has been widely available only in pill or film form, which must be taken daily and held in the mouth or under the tongue for 15 minutes for maximum efficacy.
However, expanding the use and varieties of medication-assisted therapy options, including buprenorphine treatment, was set as an official target for the FDA’s Opioid Action Plan in February 2016. It was also listed as one of the U.S. Department of Health and Human Services’ (HHS) top three priorities for reducing opioid- and heroin-related deaths and dependence across the country. Perhaps this is why the FDA decided to give probuphine another chance.
“There is no question that long-acting, implantable buprenorphine will have a meaningful role in the treatment of opiate addiction,” said David Pickar, MD, professor of psychiatry at Johns Hopkins University, in a recent email exchange about the drug. As a member of the FDA advisory committee, Pickar voted in favor of approving the implant earlier this year. “It adds to the growing list of pharmacological interventions for this serious illness. While there are limitations to its effectiveness, it nevertheless will have a real place in treatment and likely will save lives.”
Pickar says he made his decision largely in response to new data on probuphine released in a recent Phase III clinical trial, that showed 85.7 percent of people who received the probuphine implant stayed off of illicit opioids for at least four months of getting the treatment. That’s compared with an efficacy rate of 71.9 percent in people who received the older, oral versions of buprenorphine.
This was a major breakthrough, said study authors, as the trial set out only to prove that probuphine could work as well as the oral form of the drug.
“We originally licensed probuphine in 2012, thinking they would approve the drug back in 2013. But the application was denied, due to what the FDA deemed a faulty trial design,” explains Behshad Sheldon, CEO and executive director of Braeburn Pharmaceuticals, who spoke to us just hours before the FDA ruled to approve probuphine for use in the United States.
According to Sheldon, past clinical trials showed that probuphine performed better than a placebo in people who were new to an MAT regimen. However, federal officials said they were concerned that the drug did not contain a high enough dose of buprenorphine to be clinically meaningful. The FDA also expressed concerns over the set-up of training programs that needed to be organized for doctors to be able to implant and remove the device safely, as well as recommendations over the types of people with opioid dependence best suited for the drug.
“The original two efficacy studies conducted by Titan were in patients who were brand- new to treatment, so yesterday they were on heroin, then the next day they were in the clinical trial,” explains Sheldon. “But from a common sense standpoint, it makes sense to put a six-month implant in someone who is already doing well [on buprenorphine therapy]. So we came to an agreement with the FDA on the right study design to test in a more stable patient population.”
Over the next two years, Braeburn, Titan and the FDA worked together closely to bring the implant up to agency standards. In August 2015, the drugmakers re-submitted their New Drug Application (NDA) to the agency, which accepted it a month later. However, in February, just after the FDA panel recommended approval of probuphine, the agency decided to extended its decision deadline on probuphine by two months.
Throughout the waiting period, addiction advocates pushed federal authorities to hasten the approval of probuphine with letters, position papers and advocacy initiatives. According to Sheldon, at the time of the extension, thousands of doctors across the country had already signed up to become certified in inserting and removing the device. Now that probuphine is approved, the roll-out of the drug to addiction recovery facilities across the country will begin in just a few weeks.
Addiction treatment specialists and advocates who have been fighting for probuphine since 2013 say there are a few major advantages to using the implantable buprenorphine treatment over the traditional oral versions of the drug.
Obviously, there is the advantage of adherence. The probuphine implant would also spare people hoping to kick their addiction the hassle and often stigmatizing experience of having their buprenorphine prescriptions filled by a pharmacist. Plus, the implant drastically cuts back on the chances of diverting buprenorphine, which many advocates argue holds back the number of doctors willing to prescribe MAT in the first place. Currently, legal buprenorphine is the third-most confiscated opioid drug by the U.S Drug Enforcement Administration (DEA), a fact that makes many doctors wary of prescribing it to their patients over other drug-free regimens.
“Although the FDA has recently approved other buprenorphine products, none fill the specific needs that the implant can, especially one that cannot be diverted, cannot be overdose[d] on, cannot be stolen, sold or lost, cannot be abruptly stopped by the patient, and carries no risk of accidental pediatric exposure,” argued activists at the National Alliance of Advocates for Buprenorphine Treatment (NAABT), a Connecticut-based nonprofit that aims to educate the public about opioid addiction and available treatments. In the months leading up to FDA approval, the NAABT launched several letters and position papers to help open up access to probuphine across the country.
NAABT also pointed out some specific subgroups that may benefit from the probuphine implant over traditional buprenorphine therapies, such as people who need to travel abroad, or people like truck drivers, flight attendants and others who travel on the job and may not be able to fill a prescription at the same place every month. Advocates also argued that the device virtually assured medication compliance for the first six months of treatment, “arguably the most important period,” and pointed out its promise in places like prisons, where buprenorphine is often diverted.
However, some addiction treatment specialists are wary of the lofty promises made by the new device. Robert Ben Mitchell, D.O., who runs an office-based opioid treatment facility in Miami, and has been working in the field of MAT for the last 15 years, says he is still going to rely on traditional buprenorphine treatment for his practice.
“It allows patients to manage individual dosages, including reducing and/or skipping dosages as they feel able to do so. This, in turn, allows patients to self-wean off the medication when they are ready. You can’t do that with probuphine,” argues Mitchell. No matter what, the device will deliver around 8 mg of buprenorphine into the body, which, although considered to be a “moderate” dose of the drug, can be a much higher dose than what some patients take to help manage their opioid addiction with oral forms of buprenorphine.
Another major concern among critics of probuphine is the unintended effects of having a constant dose of buprenorphine in the blood in the event of an accident or major surgery.
“Can you imagine having an emergency appendectomy or bone fractures set after a car accident and not being able to use pain medication for two to three days after your operation because you have [the] probuphine [implant] inside of you?” Mitchell asks. In fact, the FDA has voiced its own concerns about possible complications of removing and inserting the device in these scenarios. Federal health authorities have also raised concerns in the past that some patients with the probuphine treatment still needed oral buprenorphine as “rescue medication” when switching over to the implant, proof that treating addiction may not be as simple as a regimented implant.
There’s also a big question going around among addiction advocates over the price of probuphine. Behshad Sheldon, CEO of Braeburn Pharmaceuticals told us that the cost of probuphine will be “competitive” with “other long-acting treatments,” such as Vivitrol, a buprenorphine injection that costs around $1,000 a month. According to a recent press release from the company, probuphine will cost $4,950 for a six-month course of treatment. Comparatively, the price of traditional buprenorphine treatment is about half of that, costing around $500 a month, including doctors visits.
However, FDA approval doesn’t mean that addiction treatment specialists across the country will be forced to prescribe the drug to their patients. Instead, Braeburn and Titan hope to position probuphine as yet another tool in the anti-addiction arsenal, meant for specific patients who are searching for a more tailored approach to buprenorphine treatment.
In fact, current recommendations by both drugmakers call for probuphine to be prescribed only in cases where a person has spent three months without exhibiting any evidence of illegal opioid use and at least six months taking 8 mg or less of oral buprenorphine daily. The device also must be used as part of a complete addiction treatment program, involving counseling and psychosocial support.
Common side effects of getting the probuphine implant include injection-site pain, itching and redness. From then on, the drug’s effects so far seem to be similar to that of traditional buprenorphine treatments, including headache, depression, constipation, nausea, vomiting, back pain, toothache and throat pain. Studies also show that the implant may help cut back on some of the gastrointestinal distress caused by buprenorphine patches and pills.
When can we expect probuphine to make it to U.S. markets? “We’ll probably need about three weeks to actually finish the packaging and print prescribing info, and then, most importantly, we will be starting the training program with physicians who need to be certified on how to implant and remove the device,” says Braeburn Pharmaceuticals’ Sheldon.
According to official plans set out by drugmakers, doctor trainings on the probuphine implant will last four hours and will take place on Fridays, Saturdays and Sundays, per doctors’ requests. Sheldon says the trainings focus first on the states with the highest number of overdose deaths, and in areas where buprenorphine is already widely used. New York and Los Angeles currently have the largest number of pre-registered doctors for the probuphine trainings, however, a wide array of training programs in smaller cities, especially in the Midwest, have also been set up.
“We’re trying to go to the people instead of making them come to us,” says Sheldon. To date, Braeburn has set up 262 probuphine trainings across 55 cities, and almost 5,000 doctors have already signed up for the classes. Last weekend, Braeburn conducted its first training session, certifying the first 121 doctors in the country on how to insert and remove the implant.
Now that FDA approval is official, drugmakers are also looking at expanded uses for probuphine, including its future potential as an opioid alternative for patients with chronic pain.
“We’ve had a lot of interest from clinicians who told us that they already use buprenorphine for pain in some instances,” says Sheldon, noting that the opioid alternative is far less addictive in many instances than traditional prescription painkillers. Braeburn aims to start talks with the FDA around probuphine’s use for chronic pain immediately, but the testing involved in pushing that next approval endeavor is likely to take a few years.
So while the push to approve the new buprenorphine implant as America’s next tool to combat its growing opioid crisis has been successful, it may take a few years to see probuphine’s potential in this arena fully realized. In the meantime, drugmakers and advocates alike are celebrating the FDA’s decision as a major move forward in the way this country is addressing the millions of people struggling with addiction.
Remember the "societal outcomes" study published by Braeburn showing usage of probuphine would result in 80% reduction in rehab visits by patients. That's her bread and butter. She probably read that and freaked!
I didn't find any direct link, but she is listed on the suboxone directory (whatever that is)
http://www.suboxone-directory.com/suboxone/dr-indra-cidambi/
I think it's more likely she's worried about losing business. She is the Medical Director at New Jersey’s first licensed outpatient detox facility, Center for Network Therapy (CNT). In the link below, she tears into "in-patient" rehab centers...because they take away her business.
http://www.prweb.com/releases/2016/02/prweb13218337.htm
So basically, she's willing to bad mouth anything that doesn't bring patients into her center.
Not to mention monthly prescription numbers (sales!) and a possible EU license deal (due diligence has started after all).
That could be what happened. I just got pissed today and put a limit sell order in at $50 a share so they couldn't be used for shorting, and they called within an hour.
19 million shares traded since the 23rd of May. Shorts smell blood in the water so they won't be going away soon. Oh well, I can wait.
Dr. Cidambi (Long)
1. The name sounded familiar. She is a psychiatrist. She has a vested interest in patients coming to see her every week. Probuphine potentially gets in the way of that. From last week's NPR piece:
In the meantime, some doctors say they will hold off on using the implant. Dr. Indra Cidambi, who treats addiction patients in New Jersey, says she's worried patients will assume it's enough, that they don't need the check-ups or the counseling that are part of most recovery programs.
"Probuphine is set up for failure in that way," said Cidambi, "because the patient will be seen after six months and in the meantime, they're not going to be following up with therapy. And that means it's not going to be medication assisted therapy — it is medication maintenance only."
http://www.npr.org/sections/health-shots/2016/05/27/479755813/long-acting-opioid-treatment-could-be-available-in-a-month
2. According to her web listings and the article linked below, she is happy to prescribe suboxone to her patients. So all of the buprenorphine related criticisms in her article would also apply to suboxone, which she prescribes to her own patients. So what’s the deal?
3. She can’t do the implant procedure. Admitted as much earlier this year:
“…these implantables are not conducive for the common prescribers, what do I mean by that, and that if you see the Buprenorphine that’s being prescribed 32% of the prescriptions for Buprenorphine, naloxone sublingual tablets are the pills have been written by General Practitioners, Family Medicine Practitioners and Doctor of Osteopathy. While some of these guys are prepared to do some minor surgical procedure while others are not because they implant itself is a minor surgical procedure, okay. So 22% of the Suboxone prescriptions were written by psychiatrists, these professions are not trained to do a minor surgical procedure, but even that’s not a big deal. You can train these, the doctors and we can get that thing but then we don’t have offices that are equipped to do this kind of minor surgical procedure there. So that is a big issue, even if the Probuphine, the marketed….
http://healthprofessionalradio.com.au/2016/02/26/dr-indra-cidambi-ambulatory-detox/
Charles Schwab just called me an offered 2% per annum interest to allow them to borrow my shares for short sales! That's never happened to me before.
I said no.
Turks, If you're like me, you have to wait for the bi-monthly reports from Nasdaq. I know FINRA reports short selling, but it's never clear to me how much of that selling is just market makers filling orders vs. actual short positions.
What I can't wait to see is the 13F's that will be reported as of 6-30...I'd like to know whether any institutions have bought in. They all left town as of 3-31 (didn't want to hold through approval).
http://www.nasdaq.com/symbol/ttnp/institutional-holdings
They have to cover sooner or later...but what do I know. Encouraged to see the Form 4 reporting that a board member bought 20,000 shares at $7.00 a share yesterday. Hard for me to believe the shorts are correct and this guy is wrong:
James R. McNab, Jr. has served since 1998 as chief executive officer and chairman of Palmetto Pharmaceuticals, Inc., a privately-held drug discovery company he founded. He has been a chairman of the board of directors of Curis, Inc. (Nasdaq:CRIS), an oncology focused biotechnology company, since May 2002. Since 2009, Mr. McNab has served as executive chairman of FirstString Research, Inc., a privately-held biopharmaceutical company, and as chief executive officer of JT Pharmaceuticals, Inc., a privately-held drug discovery company. Mr. McNab has co-founded several privately-held companies, including Sontra Medical Corporation, a drug delivery company, and Parker Medical Associates, a manufacturer and worldwide supplier of orthopedic and sports-related products. He received a B.A. in economics from Davidson College and an M.B.A. from the University of North Carolina at Chapel Hill. Based on Mr. McNab’s extensive management experience in the pharmaceutical industry, our Board believes that Mr. McNab has the appropriate set of skills to serve as a member of the Board.
I agree. I assumed the "rebate" would just be some formula negotiated with the insurance companies based on cost and the level of insurance the patient had paid for. Braeburn's "value based" formula actually provides an incentive for insurance companies to allow probuphine coverage. If you end up paying more, says Braeburn, we will refund you the money.
If probuphine works as well as it has in clinical trials, there will be many fewer emergency room visits, accidental overdoses or ingestions and detox and rehab stays. Which will save insurance companies and hospitals money...far more money than they will pay for the full price of probuphine ($4,950 a treatment).
That is pretty unique, and at least to me, pretty compelling.