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Distribution deal w/Walgreen is a significant tailwind as it will broaden the appeal of probuphine for MD's who would/could not economically manage the inventory, billing, etc.. that being said, this management is long in the tooth, with bungling failures in their resumes and should have gone after this distribution method in 2016 when they had a longer nun-way time to patent expiration.. management is sub-par and the price of the stock reflects this, so does all the modification of term w/Molteni who have gotten huge concessions for a pittance just so TTNP could keep the lights on and pay unearned salaries of far too many people. the perception that management is incompetent and only focused on burning other people's money for decades is a huge headwind for this stock until they can sustain their business from organic growth of meaningful sales ... not rely on printing paper stock certificates and warrants
Upcoming areas of possible news is EMA approval timeline, why has probuphine not yet been approved in the EU?; Knight Therapeutics report of probuphine sales in Canada;... status of 6 month experiment in Probuphine w/dept of correction in Nevada (despite ICER study that opined long acting inject-able MAP has no cost benefit advantage (generic buprenorphine works just as well, despite diversion issues)...any indications of pain management approval... any FDA news of required clinical trials post approval, etc
yup, did that math too, saw same thing you did; didn't expect much but hoped to hear "we've reduced the price" to get traction with insurance and other providers so they can get volume revenue and some operating CASH; the marketing strategy sounds pretty much like Braeburn; remember, even in the prison system methadone and generic buprenorphine is way cheaper than probuphine; as for diversion, methadone is dispensed in liquid form with a DOT (direct observation therapy) protocol, meaning the nurse who administers it watches the patient drink it; same in the community ---- can't cheek that! maybe Knight and Molteni will pull rabbit out of a hat, TTNP management still running on fumes unless and until they generate cash from product sold to pay for their expenses
Buprenorphine for depression.,trauma, anxiety...
https://www.psychiatryadvisor.com/depression-advisor/opioid-system-foundation-for-social-risk-and-reward/article/803037/
“The ability of buprenorphine to normalize social interaction deficits was associated with restoring normal opioid receptor function in key brain areas,” said Irwin Lucki, PhD, professor and chair of pharmacology at the Uniformed Services University in Bethesda, Maryland. “Targeting opioid receptors to restore normal opioidergic tone can be beneficial in treating subjects with social anhedonia following trauma or exposure to high-stress situations.”
in an implant form, this would be significant... if it were in the hands of anyone other than TTNP
So ICER models show that while Probuphine is costlier than suboxone film & methadone MAT, it is less expensive than all the other injectables incl INVVY & ALKS Vivitrol... & while they have no price yet on Braeburn's CAM2038, as it has not yet been approved, if Braeburn prices it in line w/the other shots, it will be less cost effective than Probuphine
not fully understand the methodology on effectiveness of MAT for film & methadone vs the diversion potential of both relative to the injectables & the implant ... but it is good news that Probuphine beats the injectables as far as cost effectiveness..
now if TTNP reduces the probuphine price, they may have a runaway winner in terms of units sold & finally realize some meaningful profit ... one can only hope and wish
https://www.biocentury.com/bc-extra/company-news/2018-09-10/icer-finds-opioid-use-disorder-treatments-are-not-cost-effective
well it leverages the staff on hand so the doors may not close as quickly as some thought ... looked up Revex which was discontinued but not because of safety, but for "business reasons".... it didn't take off possibly due to pricing?... sounds like a familiar story.. if TTNP doesn't cut price of Probuphine, well?... still it may be a hail Mary
https://www.federalregister.gov/documents/2017/11/03/2017-23952/determination-that-revex-nalmefene-hydrochloride-injection-01-milligram-basemilliliter-and-10
"After considering the citizen petition (and comments submitted to the docket) and reviewing Agency records, and based on the information we have at this time, FDA has determined under §?314.161 that REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of REVEX (nalmefene hydrochloride injection), 0.1 mg base/mL and 1.0 mg base/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness."
agree.. 0 reason to continue to employ the staff on hand based on their dwindling cash...I fervently hope that each member of the BOD is held personally liable for their lack of oversight on this company's spending...not sure if they are counting on Errors & Omissions insurance to cover their legal expenses from any lawsuits by shareholders but they, collectively & individually have breached their fiduciary responsibility to public shareholders in allowing the gross mismanagement of this company for years.. as I have said many times before... if it was my business and my cash I would have terminated all staff long ago, terminated lease on building, run the business from a virtual office, focus on selling to prisons/jails, HMO's, & the VA etc by cutting the price to promote adoption & generate dollars... especially appealing to self-funded ventures noted above who have the medical staff on hand to do the procedure but who also are constrained w/tight budgets & constantly must evaluate the fiscal risk/benefit of costly implant vs generic oral buprenorphine... really not much more to say
true enough about the pricing effectively killing it...
to shelve it would expose INVVV to the same legal challenges it faces on anti-competition when they stopped manufacturing their oral suboxone pill to favor their film, before generic was available ... I always believed the roll out market for this product should have been to self-funded entities like Kaiser HMO, VA, prison system...no insurance required and medical staff on hand to do procedures... fussing w/individual providers reliant on insurance reimburses & having medical personnel to insert/remove the rods is not profitable for small MAT programs run by one doc who passes out buprenorphine pills and maybe can handle an injection ... all that being said, ALKS already has a relationship w/prison systems as they pushed their vivitrol at the expense of buprenorphine by convincing wardens it was the only "non-narcotic solution"... the ALKS CEO has changed his tune, saying every modality approved by FDA should be available to everyone.... I think ALKS can profit by bringing this probuphine in their fold...not the least of which is they have the capability to manufacture as well as to distribute to a closed system... TTNP's ability to get this off the ground on their own?... market doesn't think so
thought about that... but Molteni is tiny... their cash stake is teeny @ this point & I venture they will take a deal for a profit... they appear to be prudent in their risk profile given how they structured the original deal
while it appears to be good news that Brawburn abandoned Probuphine ... the outlook is not clear in terms of commercial viability in TTNP's hands... in reviewing Braeburn's old S1 which lists some of the potential risks I have lots of questions on sourcing the EVA and the purchase of the buprenorphine from Teva .. + what is the status of the post approval trials requested from FDA... what about pain... on and on and on.... TTNP is not usually forthcoming w/information which may clarify a path forward for investors ... my hope continues to be that a larger competitor buys them out... on my short list would be: INVVY, ALKS, TEVA
down 20% and the silence from TTNP is deafening
part of medication assisted treatment (MAT) for opiate use disorder ... currently not available in most prisons .. as the article states what is available is AA meetings: "CDCR officials note that ... all of the state's prisons offer other self-help groups focused on recovery"... that's shorthand for AA meetings. While AA is a great support it is not in and of itself efficacious as the sole intervention for opiate treatment!
1 dead 11 sent to outside ER's in California prison: https://www.kqed.org/news/11665693/fentanyl-blamed-for-apparent-overdoses-that-killed-california-prisoner-sickened-others
and TTNP employees just keep lining their pockets; they are by far the smartest people in the world. Since 2005 they've burned millions of other people's money and have handsomely enriched themselves; they go to an office every day and play like they're working. why not? no oversight no bosses, nothing; the dollars flow in their personal accounts every month; who wouldn't want a gig like that? If you rob a convenience store of $500 you go to jail; if you suck a company dry of MILLIONS you get to retire on the beach-something wrong with this picture?
Bravo FDA ... challenging efficacy not just rubber stamping ALKS new drug idea to market another bottle of miracle cure... looking at ALL phase 3 not just the ones that showed statistically significant results that the company said validated their drug... companies are notorious for choosing the studies that validate their thesis and dropping the ones that don't...oh and the CEO's breathless comment on the CC call yesterday that there have been no pharmacological advances for major depression for the past 30 years as a reason for the FDA to rush another drug to market belies the fact that studies have shown that medication and CBT therapy are equally effective after 6 months but that CBT effectiveness lasts years after completion while medication effectiveness diminishes rapidly after the medication is stopped .. as for pharmacological interventions.. take a look at this link form UCSD on alternatives ... https://health.ucsd.edu/news/features/Pages/2018-01-03-q-and-a-ketamine-for-depression.aspx
almost identical spike on OPNT.. at the same time...
Saw that.. FDA catching up w/scientific evidence of addiction treatment (not the case when probuphine approved).. I would think TTNP employees would have jumped on this and requested waiver in light of FDA's evolving position
"Another hind-site revelation has been that sublingual/transmucosal bupe still has a ritual aspect to it. The body/mind expects the drug, even though the half-life is long with bupe, you can still feel the dose swings and there is a “kick” after dosing"... well said! this is the problem w/all drugs incl methadone or buprenophine strips or pills... the craving rush at the visual cue or the ritual associated with it feels like one has just ingested the actual drug of abuse and gets a high... that's one of the reasons a key tenet of Alcoholics Anonymous for people in recovery is to "stay away from people places and things" that have any association w/drug use... the cravings are that strong!.. nice to see the testimonial that probuphine does not activate that visual/ritual cue...
points well taken.. every single one echoes sentiments that I've passed on to the Congressional committee chairman & ranking democrat synthesizing the very arguments their own witnesses made in that video... I recommended they deploy the resources of 2 key agencies to remedy the lack of efficacious treatment we the taxpayers fund. first and foremost the DEA should lift the constraints on MAT treatment... I've posted the link before on this board of The Wall Street Journal video by Jason Bellini that elegantly and succinctly illuminates the problem of misdirected funds toward possibly ineffective treatment as he showcases Dr. Sara Wakeman's statements on the standard of care. Secondly, I pointed out in my letter to the committee that they consider requiring SAMHSA, who commands a 3.9 BILLION budget for 2018, to administer grants it annually doles out to States for opiate treatment to include metrics for efficacy .. currently they do not.. they allocate funds by formula and some compliance metrics.... right at this moment if I wanted to know the names of the most successful treatment providers for opiate addiction, I wouldn't be able to find anything resembling a ranking on the SAMHSA web site... did I mention their budget for 2018 is 3.9 BILLION? .. yes I did.. I realize this is a TTNP stock message board & not a social forum for addiction treatment, but honestly the 2 are intertwined and this issue to me is way more critical than TTNP's price.. 64,000 people died in 2016.. unfathomable that we're still tinkering around the edges of this epidemic
FDA to expand MAT for Opioid Addicts
https://www.nytimes.com/2018/02/25/science/fda-medication-assisted-therapy.html
"Noting federal data showing that only one-third of specialty substance abuse treatment programs offer medication-assisted treatment, Mr. Azar said, “We want to raise that number — in fact, it will be nigh impossible to turn the tide on this epidemic without doing so.”
"The F.D.A. has approved three drugs for opioid treatment — buprenorphine (often known by the brand name Suboxone), methadone and naltrexone (known by the brand name Vivitrol) — and says they are safe and effective combined with counseling and other support. But the agency said it would soon publish two guidances, recommendations for drugmakers, on the issue.
One encourages the development of new, longer-acting formulations of existing drugs for opioid treatment. The other, which was described in detail to The Times, said new drugs would be eligible for approval that don’t end addiction but help with aspects of it, such as cravings, or overdoses, with the goal remaining complete abstinence." “We will permit an endpoint that shows substantial reductions but does not require the patient to be totally clean at every visit if the measurements are fairly frequent,” a senior F.D.A. official said."
details to be released in March .. certainly lack of access will become a legal issue as measured by the "standard of care".. hence hereto mentioned lawsuits against insurance companies that deny access by claiming no medical necessity.. try establishing in court that you are not practicing contrary to the "standard of care" for someone who has died
United Healthcare demonstrates why Bezos Buffett and Dimon intend to take "friction" out of the healthcare system to reduce costs...whatever clerk approved this roadblock will probably ultimately cost United Healthcare millions in lawsuits from families who may lose a loved one... it will be interesting to see what Knight does w/probuphine in Canada.. I understand Canadians are ready to toss in the towel, skip right over injection sites and dispense opiates through vending machines because injection sites are too costly .. wow...https://www.washingtonpost.com/news/worldviews/wp/2018/01/24/the-canadian-fix-to-the-opioid-crisis-a-vending-machine-that-distributes-prescription-opioids-to-addicts/?utm_term=.b9100f08335a ... on a brighter note, I recall that listening to the congressional hearing on "Examining Concerns of Patient Brokering and Addiction Treatment Fraud", witnesses stated that 70% of addiction treatment was paid by the government and 30% was paid by insurance and out of pocket cash... one congressman said he was surprised at the ratio and thought maybe the government could demand the treatment providers demonstrate how much they actually "cure" the disease in order to get paid... makes sense to me... right now everybody who offers "treatment" gets paid, even of that treatment consists of ____( whatever) despite evidence based modalities that validate MAT, money flows everywhere without accountability metrics as evidenced by reduced relapse rates.. and the government just keeps on doling out the dough... in the addiction field that's called "enabling"...
I understand their thesis.. but for opiate treatment the gold standard at this point is MAT... I refer to the Wall Street Journal's elegant 11 min video by Jason Bellini that I've posted before: "The way to save opioid addicts";
you mirrored my thoughts.. prudent for Molteni to wait until the murky pond clears .. also good for TTNP BC if they sell the company, the less encumbered it is with itty bitty deals the better
absolutely right but if you don't get the pricing right to begin with you have no chance to recoup anything if you have no sales... strategic pricing is everything.. gross margin dollars pay the rent, not gross margin %.. retailing 101
much more goes into the "cost of sale" before the profit bottom line; sales, marketing, logistics, training docs, travel expenses, meals, etc... generic buprenophine pill requires none of that.. it's a commodity and priced accordingly.. unfortunately probuphine competed directly w/that commodity and rolled out like any other pill which made its pricing challenging for uptake... Apple Tree thought it would be a blockbuster despite the operational challenges inherent in the implant process and insurance coverage... training those DEA docs throughout the country in the belief they would themselves take a profit hit and buy the inventory in the hope they would get paid later by insurance was more than naive, it was a grave mistake (millions squandered and precious time lost) .. a more profitable strategy: much lower initial price of probuphine in line with but above the generic pill given its value in compliance, efficacy as well as non diversion profile... roll out the initial launch to: VA, HMO, prisons; all of which have staff on hand to do the minor procedure without fuss (that also would have cut the training and marketing costs significantly) ... subsequently, when insurance was on board and logistics glitches ironed out, make it available to the docs, while working with the government to make the product available to every primary care physician's office... in all fairness it's easy to see the strategic mistakes after the fact.. but that's why good business people get the big bucks.. they can foresee and act accordingly... clearly Apple Tree & TTNP management are not in that class .. hope a stronger management team takes possession because probuphine is sorely needed in the marketplace right now
That's how it works…shareholders get wiped.. So does management.. it can happen and it strengthens the negotiating position w/Braeburn to return probuphine ... if Braeburn will continue as a going concern and not just fold up shop .. In the meantime Robert E Mead has filed 13G increased stake.. Any ideas?
great analysis, thanks...I don't blame Horizon for technically calling in the loan.. TTNP running on fumes, history of poor management.. I forgot that Braeburn was on the hook to pay up to 50 mil royalty on sales if they can get injectable approved.. if Braeburn does not return probuphine and TTNP goes BK, I would imagine they would still owe the royalty (pending approval) even to the bankrupt estate .. lots of ifs ... but if TTNP publishes an S1 all will be revealed.. a silver lining in this cloud ... we will finally know
while I agree there may be > value than they will get selling the company at this juncture, management has been painting themselves into this corner for decades... getting $ from the public for far too long & returning no value to shareholders.. from their 2005 10K "In March 2004, we received net proceeds of approximately $14.4 million from the sale of our common stock. At December 31, 2004, the Company had approximately $36.3 million in cash and marketable securities".. this is 2018 and?... this company should have been sold long ago to stronger hands ... the management & board of this public company would receive an F from any kindergarten teacher in the country based on performance ... and the stock price reflects that
May 14th date is pretty precise.. agree all parties expect something to happen by that time, but Horizon is insisting on their money being returned even if equity has to be raised.. on the one hand one can infer Horizon is limiting their exposure to TTNP & securing that 3 million on the table w/ a lien on TTNP's intellectual property, though the conditions for lifting that lien are not unreasonable and a pretty low bar... on the other hand one can infer that TTNP is limiting their cash burn in terms of reduced interest payments by prepaying that exorbitantly high interest loan, without a pre-payment penalty .. seemed like a pretty fair negotiation
My understanding of amendment to loan terms
• TTNP to repay 3 mill
• TTNP to repay 1 million by May 2018 under either condition
? TTNP finds 5 million cash and pays Horizon the 1 mil or
? TTNP sells shares to pay Horizon the 1 mil
• Horizon will continue their loan to TTNP of 3 million interest only in place
? Secured now by a lien on TTNP intellectual property
§ (advantage Horizon)
? Monthly payment to Horizon on 7 mil was = $57k/month.. (TTNP has been paying Horizon since August)
§ Monthly payment to Horizon on 7 mil, given that Libor has increased, now = $62k/month
§ Eliminating 3 mil of principle, TTNP owes interest only on 4 mil = 36k/month..
§ Paying off another 1 mil by May would reduce principal to 3 mil & interest = 27k/month
? (advantage TTNP)
• No prepayment penalty as in original loan (advantage TTNP)
Disadvantage Shareholders:
• TTNP may have to raise equity if they don't get a cash infusion by May = more dilution
• TTNP has mortgaged their intellectual property for 3 mil to Horizon
how much the Gov spends or does not spend on opioid treatment is not going to impact TTNP right now... the government is spending money on treatment right & left.. just not effective treatment... as the recent congressional hearing in Dec sadly elucidates: "Examining Concerns of Patient Brokering and Addiction Treatment Fraud" https://energycommerce.house.gov/hearings/examining-concerns-patient-brokering-addiction-treatment-fraud/... bottom line, TTNP needs to get some $ quickly & resolve the situation w/Braeburn quickly in order to move forward... while the disclaimer "Past performance is no guarantee of future results" may be true, the corollary is also true that the future is predicated on what has come before.. and w/TTNP, moving quickly is not something they have ever demonstrated, so people are bailing.. we will see
you make sense .. unfortunately our government often does not... they would probably not approve of telemedicine unless UA available to the rural population to establish abstinence.. then the wild wild west of fraud that has spawned shady treatment providers & shadier compliance "businessmen" who are cashing in way more $ through UA billing than the drug dealers selling on the street corner...http://www.9news.com/article/news/investigations/medical-cost/how-peeing-in-a-cup-can-cost-you-6250/73-437500908... one wonders who's minding the store.. the taxpayer store that is... NYT published an article this wk "One son, 4 overdoses, 6 hours"...https://www.nytimes.com/2018/01/21/us/opioid-addiction-treatment-families.html.. I took the survey @ the end of the article.. while the opiate epidemic is a multi-faceted problem.. multiple gov agencies that spend billions have done nothing & no one is holding them accountable.. I suggested the reporter ask our politicians what responsibility and accountability SAMHSA bears for this mess.. they regulate the methadone clinics etc.. they put out tons of feel-good papers, spread $ grants around the country.. so I ask.. if I took out a 60k mortgage to send my addicted child to an inpatient treatment facility for a month, where on the SAMHSA site do I go to find the most successful one in my area?.... oh BTW SAMSHA FY2017 requested a budget of 4.3 Billion an increase of .5B from 2016.. any idea where the money went?.. google substance abuse treatment fraud in California right now.. no one's minding this store either.. the fraud is rampant, the bureaucracies that are supposed to be regulating all this are fully funded, and yet no accountability ... sorry, enough soap box
nice video clip on bottom of article on the benefits of probuphine for one young lady..
https://www.usnews.com/news/us/articles/2018-01-23/trump-administration-expands-access-to-opioid-medication
right.. but a chore & $$ to haul them into court quickly to litigate the clause.. Braeburn can transfer itself & assets to anyone for a $1 (they are private).. possible obstacle may be clauses in new funding .. but who knows the terms.. "$110 million mezzanine round of financing led by Wellington Capital Management. Other new investors participating in the financing include Avista Capital Partners, RA Capital Management, New Leaf Venture Partners, Deerfield Management, and Rock Springs Capital".. $ were targeted specifically for dev & marketing cam2038 https://www.prnewswire.com/news-releases/braeburn-announces-completion-of-110-million-financing-300581077.html .. besides probuphine all Braeburn is advertising on their web site is cam2038..
I believe they were tasked also to complete some post approval clin trials on probuphine & advance prubuphine for pain.. but haven't seen any of that either..
also wondering what Braeburn owes Camurus AB for the rights to CAM2038 .. CAMX is moving right along in EU to get Cam2038 approved..https://www.bloomberg.com/quote/CAMX:SS...
or they can sell it to someone else... don't know if there was an assignment clause in the licencing agreement...
thank you for the articles.. interesting read.. while many are focused on chronic physical pain.. the issue of emotional pain blunted by opioids is not likely going to go away even if every one of these drugs makes it to market.. interesting that ALKS, in their quest for a depression magic bullet, is also flirting around w/Kappa... this article might be of interest...
http://blogs.sciencemag.org/pipeline/archives/2016/01/29/alkermes-hits-a-wall-in-depression
TTNP has a delivery system.. that's all.. they made seriously poor choices and wasted a lot of time while their patent is expiring ... they are in a poor negotiating position right now given their financial straights... IF they can retrieve the licence quickly from Braeburn their value will increase for a buy out... will see
well well the mouse that roared.. Braeburn in a tough spot to negotiate any royalty based on probuphine revenue so far.. that's how the math goes.. as far as being tied up for years in litigation.. maybe not.. we are not privy to the terms of the recent funding deal for 110 mil.. it may have been conditional on approval of injectable ... who knows.. present value of probuphine negligible.. Braeburn running on fumes and fighting to keep probuphine will drain resources they don't have... Apple Tree may cut their losses and move on.. we will see
you all are the best.. thanks for the timely post.. I looked yesterday & did not uncover...
question from the PR.. "CAM2038 would be the first and only injectable for OUD that can be administered by healthcare professionals from Day 1 of a patient's OUD treatment".. INVVY inject-able not able to be used immediately?
I believe it will be a positive for probuphine as Braeburn will be able to scale its injectable & implant into a suite of treatments (of sorts).. the fact that they received additional funding will power not only the injectable but probuphine as well... per their S1, Braeburn was in danger of folding.. "going concern" note from auditors, w/out an infusion of cash.. now they have a bit of change to work with.. they gotta make all of their stuff pay or they're on the ropes... TTNP is a cautionary tale for them of a company running on fumes.. so it goes
current evidence based science: addiction is a brain disease & it is chronic... which means it cannot be "cured" but it can be effectively managed... in the future, a "cure" may be uncovered but as of now, management of this chronic condition that carries a high relapse rate is all we've got to work with
one possible + Apple Tree may be banking on is that their shot does not need refrigeration while Indivior's does... while a nurse can administer the shot, it still needs to be closely monitored by MD.. as the end of the month comes, cravings can spike ...psychiatrists I know struggle to keep consistent meds in a person's system w/inject able antipsychotics.. unless court ordered, many patients want off the injectables as soon as possible... we will see what the relapse rate will be on the buprenorphine shots .. at 1k per shot.. (if that's the price) insurers will require results .. such as negative UA.. we will see how that goes on an outpatient basis ... right now it's cheaper to pass out pills.. to me the 6 month implant is more efficacious for those who want to taper down.. I see more value in probuphine... but then again, the price of TTNP says I'm wrong .. humbling..good for Apple Tree they got others to share the risk.... couldn't get the $ from the market.. so they reached out to Deerfield... as TTNP knows, their dough doesn't come cheap, who knows what concessions Apple Tree made