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Can’t wait to watch those insurance worms squirm when Christie’s panel convenes …. I’ll be popping popcorn .... Kennedy spoke passionately about the 10yr old Mental Health & Substance Abuse Parity Act & he recommended contacting the State Attorney Generals to sue the insurance companies ….to which Christie added that 70% of the employer provider insurance plans in the States are regulated by the federal dep of labor not the states...Gov Christie said: "we need the federal dept of labor to step up and enforce the parity act"... preliminary data indicates that in 2016 64,000 citizens died from drug overdoses… if the States don’t sue those worms, if the Federal Govt doesn’t sue those worms.. I’m thinking loved ones of those 64,000 souls might have standing to pry $ from those deep pocketed worms
https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
Vivitrol = 25% of ALKS revenue according to this article
http://fortune.com/2016/09/26/biotech-alkermes-drug-addiction-medication/
hoping TTNP has not locked up anything w/OPNT & they are just collaborating.. also hoping that the EVA will work for the antagonist... if so, then TTNP shareholders can breathe... I don't see Braeburn buying TTNP... will find it hard to keep their doors open.. venture capital from Apple can't keep it afloat forever ...they're working on "me too" injectables to compete with whom?.. right...I see much > value in an inplantable than an injectable and a current competitive advantage ... probuphine franchise may be up for sale sometime soon if Braeburn does not start generating cash.. read the article above on how Vivitrol endured despite initial failure (thanks to a plucky CEO)... I wish ALKS the best on their upcoming depression drug .. their CEO is a fighter & a visionary.. I would bet on him
IMHO Alkermes can't doddle and lose competitive advantage to an implantable antagonist.. Vivitrol is their flagship.. they may act sooner rather than later to protect their franchise
http://fortune.com/2016/09/26/biotech-alkermes-drug-addiction-medication/
Narcan administered as a spray is just as effective as IV
http://www.tandfonline.com/doi/abs/10.3109/10826089409047912
perhaps... but the price of OPNT has rocketed from $5 in mid June to a high of $51 by early Sept; currently $36.79.. while on the other hand the price of TTNP dropped from $2.5 in June to a LOW of $1.3 by late August; currently $1.75.... never mind that since last Nov high of $6.11 TTNP is now trading at $1.75, scraping the bottom of OTC land .. so on that metric alone, which CEO would one bet on
thank you for the link... learned much.. will run through it again to fully integrate all the information... not impressed w/Braeburn's presentation relative to some of the others... applauded Alkermes response to Gov Baker's question/comment...re: agonist vs antagonist treatment.. "no one size fits all"... ABSOLUTELY...watched the reaction around the table when Opient announced collaboration w/TTNP.. this will be getting interesting... bottom line TTNP has no $ to bring anything to fruition w/out deep pocket partner.. so who'se it to be.. as I said before, either Indivior or Alkermes would be a great partner to buy the delivery system as it can be used for both agonist & antagonist... the advantage of an implant over a monthly injectable for an antagonist is the implant can be removed in an emergency.. an injectable can not
Apple Tree was hoping to IPO & fund Braeburn with other people's money .. their S1, however, laid bare that Braeburn's strategy was not going to generate cash anytime soon... investor's did not take a bite .. so Apple Tree has limited options @this time.. sink > $ into Braeburn or sell assets & fold the company... agree it's generally good news for TTNP.. Braeburn will either sell their probuphine rights or focus resources on making it a success.. still hoping stronger entity buys the entire franchise in order to maximize the drug delivery potential of proneura... as I said before, Apple Tree will find it difficult to compete w/Indivior or Alkemes ... the depot shots are a crowded field in schizophrenia... in addition, it is very difficult to get consents from impaired patients who often do not want any medication at all, much less a long acting shot.. even in a prison setting getting a court order to force a PT even to take oral psychotropic medication requires convincing a judge that the PT's safety depends on him being involuntarily medicated against his will.. court orders, if granted, expire after a year and must again be renewed in court .. in the community, most agencies that I know of will not even attempt to go to court for an involuntary order to medicate .... I suspect Apple Tree did not consult field clinicians when they were hatching their strategic plan.... as for TTNP, right now it too needs cash
Pre-approval hurdles for opiate addiction treatment as well as required pre - approval for less addictive pain alternatives may be coming home to roost for insurance companies..
https://www.nytimes.com/2017/09/17/health/opioid-painkillers-insurance-companies.html?hp&action=click&pgtype=Homepage&clickSource=story-heading&module=first-column-region®ion=top-news&WT.nav=top-news
Glad you brought up suicide.. was just investigating the suicide link to drug abuse.. particularly mandated cold turkey stopping the use of drugs, which often serve an adaptive purpose for those who use... apart & beyond the biological addiction of the substances, drug use serves a need; therefore: 1. when that need is no longer mediated by drugs, & that need is not addressed by other means, does that heighten the risk for suicide? & 2. do the drugs themselves increase suicide ideation, (as some antidepressants have been known to do)?.. bottom line there is a link to drug use & suicide, particularly opioid use.. read Nora Volkow's blog .. National Institute of Drug Abuse (NIDA) "Opioid Use Disorders and Suicide: A Hidden Tragedy (Guest Blog)" https://www.drugabuse.gov/about-nida/noras-blog/2017/04/opioid-use-disorders-suicide-hidden-tragedy-guest-blog
Declaring a national emergency?.. not going to help expedite complex treatment... unless the VA with its independent resources spearheads the response.. passing out naloxone (suggested in the article you mentioned) demonstrates lack of understanding because tolerance decreases after detox yet the addict may use the same dose as in the past, leading to death... much easier to send the national guard w/food, water & shelter to devastated hurricane areas as an emergency response than to mobilize the army to fight drug abuse.. not the forte of this administration .. conflicted in and of itself w/its continued focus on war on drugs which focuses on supply as opposed to treatment for drug users which is all about decreasing demand..
as far as TTNP is concerned the only hope they have at this point is to sell the company... not much going to help them in the short term and we are heading into tax loss selling season... w/out meaningful news, well...
Indivior lost > 1B in market value Friday due to unfavorable patent ruling that basically said Dr. Reddy's patent for suboxone film, they bought from TEVA for 70 mil, does not infringe on Indivior's patent (ouch)... the competitive space is heating up.. maybe someone will take TTNP off the shelf
the competition is moving the needle on all fronts... TTNP needs to sell the company quickly to someone who has the cash to complete clinical trials on all fronts at once in order to have a chance to make any money out of proneura before patent expires... Parkinson's dyskenesia drug news today...
http://www.marketwatch.com/story/adamas-pharma-shares-soar-on-parkinsons-dyskinesia-drug-approval-2017-08-24
You want infection stats for post approval?.. The FDA wants some post approval data too.. From Braeburn's S1.. " The FDA has required that we conduct four post-approval clinical trials to assess the insertion, localization and removal related serious adverse events of Probuphine, the risk of the QT interval in the heart's electrical cycle during treatment with Probuphine, the effect of scarring or inflammation related to a prior implant on the safety of re-implantation / reinsertion,the potential for implant migration, and the bioavailability of Probuphine into the same insertion site, and the safety, feasibility and pharmacokinetics of Probuphine implantation at alternate body sites.".. I haven't heard TTNP speak recently about results from these tests..(maybe I missed it)… given their burn rate not sure they will have enough funds till the end of 2018, regardless of their vague "we believe"… the loan terms are austere as TTNP has to shell out 665K in interest/yr.. By March 31 2018, in order to get the 2nd tranche of 3 mil, they are required to: 1. have a market cap of not < than 50 mil.. (Price has to climb north of 2 to come close)…2. report revenue from royalty not < than 750,000.. (Is that possible?) 3. Signed Partnership Probuphine Europe… (Maybe)…TTNP'S best hope is to sell the company to stronger hands as soon as they can or the sharks will circle and take the intellectual property at a fire sale… what TTNP management has shrouded in non-disclosure and generalities, the Braeburn S1 laid bare, & the price has been tanking since then… yes there is promise in the technology but the partnership w/Apple Tree was a poor choice as demonstrated by their failed attempt to market Probuphine to sole proprietor docs w/a high price point as though it was a pill they could prescribe, instead of the insurance nightmare that many sole proprietors can do without.. Braeburn missed going directly for market penetration to the VA, HMO's, jails & prisons who are not reliant on insurance reimbursal as they are self-funded.. Ultimately we all wait for that post approval data to help us make an informed decision about this product
“93% increase!!!” .. the $ don’t even begin to cover the office electric bill much less Rubin’s salary.. again to reiterate.. cut the price to GENERATE REVENUE not tout percentages which mean nothing relative to your ROI … problems w/3rd party payers?? what’s the breakdown in VA usage; what about jails what about HMOS (no 3rd party pay problems there); what about Knight sales in Canada.. Rubin spun generalities about the new Braeburn CEO from Teva.. anyone notice TEVA price lately, boy did they stumble strategically!.. Braeburn focused on depot & will find itself @ competitive disadvantage to indivior & ALKS…. What have you done Marc, Sunil & Kate to address these issues???? Braeburn is not beholden to the stockholders YOU ARE… oh the BOARD is “supportive”? Who exactly do they support.. for sure not the stockholders.... re: ROW…Kate: “we continue to make progress in our efforts to advance the regulatory review process of Probuphine in Europe”.. what happened to Australia?.. INVVY touted their planned market penetration there & elsewhere.. from INVVY CC: ” You may also remember that we interacted with a lot of ex-U.S. regulatory agencies. So we met in November-December 2016 with the TGA in Australia, Health Canada in Canada, ANSM in France, MHRA in the United Kingdom and MPA in Sweden and BfArM in Germany. Our priority right now is to submit our filing in Canada in the fourth quarter of this year´…. what exactly has TTNP accomplished in the past YEAR to access ROW?...Kate’s response: “Overall, we received strong support for our application and we're on track to submit it to the EMA later this year”… notice any difference between INVVY’s CEO update and Kate’s?.. does the BOARD question any of you 3 managers on what you r doing to enhance shareholder value? Ropinirole.. submitted NDA in Jan…Kate’s words from last CC: "Titan received verbal communication in February ...requesting additional information from us on the final release test data on the implant and on the applicator before the clinical trial proceeds... we expect to submit the requested information by the end of next month" .. so what took you so long to correct deficiency in a timely manner?… did the BOARD ASK THAT QUESTION?... oh I know, you were busy spending R&D on trial balloons like non clinical studies for malaria which you expect will generate how much $ if approved?.. the BOARD ASKING THAT QUESTION TOO?.. well never mind Kate, (what’s a measly 2.5 mil in R&D)... you were busy providing face time @ NIDA, as you said: “ And I, myself, have been participating in opioid summit with leadership from NIDA, from Health and Human Services, from FDA and NIH. That work continues”, so it’s all OK.. was Marc even at the conference call? .. sounds as though he was patched in from somewhere else… I hope someone buys the intellectual property before these people spend all the cash… IMHO, Braeburn’s strategic emphasis on depot will not net Apple Tree ROI given the competitive landscape currently against ALKS & INVYY, but that’s their problem.. TTNP needs to step it up & wake up to move beyond Braeburn & Apple Tree
MAT doesn't solve addiction..... only takes away the cravings & the hellish sickness from withdrawal so the addict can work on his/her recovery.. with help.. it's a long road & MAT is only the 1st step
SAMSHA "New Interactive Map Highlights State-Specific Trends in Opioid-Related Hospitalizations"
https://content.govdelivery.com/accounts/USSAMHSA/bulletins/1ae8f8a
"Higher drug acquisition costs for BSI (+$6,492) were outpaced, primarily by reductions in emergency room/hospital utilization (-$8,040) and criminality (-$1,212)".. While the methodology here was a simulation, reductions in ER visits in the real world I think is understated & is salient to demonstrate economic savings … particularly for insurance companies & HMO's… each ER visit clocks in @ ~ 30 K… Braeburn needs to document research on actual reduction of ER visits in area hospitals that are in the midst of the opioid epidemic to demonstrate efficacy & economic viability of BSI… (yes, I know HIPAA constraints will challenge data gathering.. But study design is key.. even small sample sizes are relevant).. thank you for posting
New Pain Management and Buprenorphine Regulations .. from the Virginia Board of Medicine newsletter .. May 2017..
“1. Can I continue to prescribe mono-product for my patients that have a demonstrated intolerance to naloxone –containing products? The answer by the current regulations is NO. There is no exception in the regulations that would permit prescribing of the mono-product in tablet form for naloxone intolerance or allergy. However, the buprenorphine mono-product may be prescribed in FDA-approved “formulations other than tablet form” pursuant to 18 VAC 85-21-150(A)(3). The Board of Medicine will consider this issue in the near future, and if a revision is made, it will be circulated to prescribers. 2. What alternatives to buprenorphine mono-product for addiction are there? This is not an endorsement for a particular medication, and there may be other alternatives unknown to the Board at this time. The only other mono-product currently FDA-approved for the treatment of addiction is the Probuphine implant. Formulations with low-dose naloxone include Zubsolv sublingual tablets and Bunavail buccal film. Methadone and Vivitrol are also options.”
https://www.dhp.virginia.gov/medicine/newsletters/BoardBrief83.pdf
not so sure about taking away uncertainty.. 7mil at 9.5% =665K interest/yr which = 2.6 million for the 4 yr term of the loan... so in effect they got not 7 mil but 4.4 million... not a whole lot of cash... interesting that the investor laid down some simple modest goals by next year that includes partnering in Europe... shouldn't the Board have done this long ago? .. everyone is putting out depot shots... that's not a panacea.. the 6 month steady state is preferable.. but then again it needs to be in the hands of a strong company in order to gain acceptance... anyone know how knight pharma is doing w/the product in Canada and how much they are charging?.. any stats on VA use?
I may have misstated the default piece as I only went off the covenants stated in the press release (unless someone has seen the actual loan agreement).. that covenant may be required in order to obtain the other tranche of 3 mil.. you're right they must be confident or desperate.. the thing is according to the press release this loan is guaranteed by ALL their assets, except intellectual property.. that means ALL the money they currently have in the bank ...this lender is taking NO chances... any whiff of default & they're toast... cannot believe that in 14 months since approval they have moved the needle forward not an inch... braeburn is doing what they need to do to recoup apple tree's capital & generate a return, clearly they have other irons in the fire as well as probuphine... what has TTNP management accomplished in that time? what has TTNP Board done to protect shareholder interests in that time?
Lenders aren’t crossing fingers, they’re insisting… 7 mil at interest only… LIBOR floor of 1.10% + 8.4% = 9.5%... round up to 10% interest that’s 700,000/yr.. one of the loan covenants is TTNP must get at least $750,000 in royalty payment or they will be in default… another covenant is they must have a market cap of not less than 50 mil .. well they have to get their price up to 2.36 to satisfy that covenant given today's outstanding shares.. oh & that doesn’t include the dilution in the warrants they issued @1.96… so including those warrants in the share count… that dilutes the price down to 2.33..lenders make a cool 100 K on that trade…and if TTNP draws the additional 3 mil, TTNP agreed to give the lender more warrants (price not yet determined)... this is a good deal?
yes an injectable will not be comparable in price to a generic pill, but it should be priced competitively in order to spur adoption of the technology that is more effective and thus will ultimately cost insurance companies less than the current ineffective sublingual or generic pill treatment they pay for.. to whit: 1 ER visit for emergency resuscitation will cost insurance about $30000.. all the medical sequalae that revolve around untreated opioid substance abuse is darn expensive for an insurance company vs the cost of the implant ... is anyone presenting data on this?... still if the price initially is significantly higher than the generic sublingual pill then that is a barrier to quick adoption of the procedure and should be adjusted accordingly
the thorn in the article ... so far they have only implanted 1 patient... therefore abysmal sales...hope Canada does better in terms of volume tied to lower price & "schools" the US folks that lower price = more $ ... cost structure of the procedure another significant barrier in the success of this
Canada is amazing in its response to health & welfare of its citizens... US, not so much.. apropos a buyout... needs to happen sooner than later ..no need to rehash reasons here.. I mentioned possible candidates in the past as ALKS & INVVY but will + a 3rd candidate TEVA.. ttnp sources the bup from TEVA & buys EVA from another supplier... TEVA has the resources to manufacture both & price probuphine competitively for volume profit world wide ... Apple Tree has been throwing millions at various ventures in hope of a hit; Braeburn will struggle to generate cash soon.. probuphine will continue to be a challenge short term & Braeburn's reliance on injectables & implants face resistance from patients & providers due to their invasive nature (as opposed to taking a pill) .. point being TEVA can probably buy the rights to US & Canada probuphine from Apple Tree for what it's currently worth.. not all that much.. & given their manufacturing & distribution infrastructure they can profit substantially by marketing the product world wide.. + because of the complicated process of manufacture for proneura, there will be a barrier to entry for other manufacturers, even after the patent expires .. win win for TEVA
Rough calculations ~ 10 mil in cash as of March, give or take/ ~ 21 mil shares; the bleeding should stop when price = .50 .. … Directors get $50,000 /year, @ least that will stop if someone buys out the company for the cash on books .. … Scott Smith from Celgene should be most ashamed of being associated w/a company of this stature as a member of the board (even 50 G a year is not worth the career smear for an up & coming executive)… the rest of the board appear to be retirees & friends of management, so 50G a year is a good gig as long as they can milk it.. … price washout was somewhat expected following Russel boot out.. then when price broke 2.05 triggered stops, when it broke 2 triggered more selling .. should stop soon .. expect short term bounce but if no good news announced soon, don’t expect people to place > $ on this management team’s talents..
subtle ... well done!
yes there will be a massive print on close.. TTNP has been under pressure for days due to the re balancing.. ultimately though one must wonder if the price has been supported as part of being included in the index and what might happen when it is not (given that the price has been under pressure since January, it's a fair concern)... some news from progress in management's lofty endeavors might give some hope
healthcare stocks down due to healthcare repeal uncertainty .. TTNP > than most BC of its other challenges .. 2 billion promised for opioid Tx under healthcare proposal will do little to address recovery
http://www.huffingtonpost.com/entry/what-the-senate-gop-health-bill-will-mean-for-opioid-treatment_us_594aeb2ce4b0a3a837bcd1aa
"A one time fund of $2 billion for addiction and mental health treatment “is pocket change” Keith Humphreys, a professor of psychiatry and behavioral sciences at Stanford University told HuffPost....“Medicaid spends more than twice that every single year so this is a massive cut to services and will likely lead to more opioid overdose deaths,” Humphreys said...“One of the things we’ve seen over and over again is that when you give people supplemental services around addiction treatment — you take care of their pain, you take care of their depression, you take care of their unmanaged hepatitis C, they’re more likely to recover,” Humphreys told Stat News...“It’s sort of like saying we’re going to treat somebody’s pancreas but not touch the rest of them. It’s really hard to do that with people,” he added. “Things tend to be interconnected.”
... of note, MNKD (often compared to TTNP) has + 150% since May .. even today it's up nearly 5%.. so not all healthcare is taking a hit... pretty much TTNP continues to be sold
difficult to say as we do not have the actual study design but going off INVVY press release...it looks as though each patient in the active group got 2 shots/month w/first 2 months = higher bup (maybe equivalent to ~ 20mg/day) & tapering off to lower dosage the last 4 months... if that was the case, the fact that the control placebo group got only 1 sham shot a month (as opposed to the active group getting 2 shots/month) would compromise the double blind integrity of the trial itself, I would think? we'll see... the point here is that competitors are vying for market share whether it's INVVY or CAMX or ALKS or someone else & TTNP board is either going to light a fire under their management to get some revenue or their whole company is going to go up in smoke
the key is pricing... to succeed probuphine must be more than competitive on pricing to demonstrate clear value and incentivize volume adoption to dominate the marketplace ... pharma folks need a page from retailing 101...think Walmart vs Bergdorf Goodman... if you are a small boutique business, your Buyers focus on GM%; if you want to dominate the market your Buyers better focus on GM$...... you don't pay the rent or pay salaries in %-- you have to generate $... right now the price comparison is generic suboxone w/value demonstrated in superiority of compliance & non-diversion.. Apple Tree can keep funneling millions into Braeburn, but until they get this math & act accordingly, their little enterprise is going to continue to be a money pit, & TTNP will go down the drain right along with them, as management & their board have demonstrated by past performance... they are clearly not the sharpest crayons in the box
RBP-6000 Indivior
1/ month shot compared to 0 buprenorphine PLACEBO? …. woohoo
So INVVY used suboxone film to stabilize their patient sample.. then, instead of continuing comparison to either generic bup & assuring placebo control by: 1 random group gets either sham shot & generic buprenorphine tablets while 2nd random group gets sham buprenorphine tablet & buprenorphine shot… they compared their monthly bup injection to no medication at all (placebo).. How is that comparable in the real world of evidence based MAT treatment.. Of course the placebo folks quit and went away..
Hopefully Investors are sufficiently schooled to see through this … why pay for a monthly injectable if daily bup might give similar efficacy (this trial doesn't answer that question) .. Maybe slightly better compliance on the monthly shot, but nowhere near the steady state of the 6 month implant… as noted in their PR release, RPB 6000 also inflicted miserable side effects on some poor souls ("injection site pruritus …vomiting… upper respiratory tract infection")
http://www.prnewswire.com/news-releases/indivior-plc-presents-results-from-the-phase-3-pivotal-study-of-rbp-6000-buprenorphine-monthly-depot-for-the-treatment-of-opioid-use-disorder-300477681.html
if this site accurately represents $ of generic suboxone pills
https://www.goodrx.com/suboxone-tablet?hide_online_pharmacies=true&show_pet_friendly_pharmacies=false
then rough calculation would = ~$750-$1000/6 months FOR GENERIC SUBOXONE..which would argue that probuphine's value will be maximised as part of a larger company's suite of offerings, given the current competitive price disparity
the Indivior anticompetitive lawsuits on their film have not yet been settled (hovering like a dark cloud over Indivior's head)... so everything is in flux for them, incl viability of their film, due to the ease with which it is being smuggled into prisons... so probuphine cost needs to be competitive w/generic suboxone w/premium paid for the superior advantage of the probuphine delivery system .. value for probuphine = significant benefit for 6 month ease of use (maximising PT compliance), non-diversion (no smuggling it to prisons or selling parts for illegal consumption, steady state release of the product (no spikes/valleys as with tablets that can precipitate cravings & relapse)
"No more funding “Advocates for Opioid Recovery” which is essentially a pension plan for Patrick Kennedy and Newt Gingrich, who have done zilch for probuphine. No more funding “Female Opioid Research and Clinical Experts” who are just another voice getting lost in all the confusion"...AMEN
S1 fast scan, addresses this issue: probuphine approved on non-inferiority to sublingual, yet poses additional costs of administration; not surprising uphill adoption; Apple T has sunk > 200 million in Braeburn & they need > cash: “Our failure to raise capital as and when needed would have a material adverse impact on our financial condition and our ability to pursue our business strategies, including but not limited to insolvency” (p89).. "if we are unable to obtain additional financing, future operations would need to be scaled back or discontinued. Accordingly, there is substantial doubt regarding our ability to continue as a going concern" (p 93) ; Sheldon may have abandoned ship… Braeburn’s pipeline currently is very risky against strong well-capitalized competitors.. . Risperidone implants = foolish venture IMHO… psychiatrists in prison have a tough time getting consent from inmates for Invega monthly shot… can’t see them even trying long term implant.. most patients stop taking these meds due to side effects they do not like… as far as involuntary medication, psychiatrists have to get a court order for a limited time to administer involuntary medication AND must demonstrate PT is danger to self, danger to others or gravely disabled to get the court’s OK.. makes probuphine look like a cake walk… so.. I’m keeping my small stake as an option for a possible buyout by stronger competitor as neither Braeburn or TTNP have the resources to make a success of this, even in the midst of this epidemic.. scenario: either INVVY or ALKS buys TTNP & the license from Apple T (both can use probuphine right now) and then both merge for a powerhouse to address the opioid conflagration .. probuphine in the right hands is a valuable treatment option to a practitioner's armamentarium for opioid treatment ..
I'll have to read the S1 tonight.. but according to clinical trials.gov Braeburn only lists 1 trial for pain & it's recruiting... it's not probuphine
Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
Condition:
Chronic Lower Back Pain
Interventions:Drug: buprenorphine; Other: Placebo
Alkermes is not the only company lobbying.. seems Indivior is lobbying their suboxone film to lawmakers .. but Maryland removed it from its Medicaid Preferred Drug List, last July… other buprenorphine products not removed.. ouch!
https://morningconsult.com/opinions/troubled-opioid-treatment-drug-maker-fights-lawsuits-policy-challenges/
.. it's not the buprenorphine, it's the film that is being smuggled into prisons, that's an issue with lawmakers
https://www.washingtonpost.com/opinions/smuggling-of-opioid-recovery-drug-furthers-addictions/2017/02/24/7fc42598-efdf-11e6-9973-c5efb7ccfb0d_story.html?utm_term=.5e618161618e
oh and not just NPR but NYT is challenging the validity and reliability of Alkermes' pitch for Vivitrol.. interesting
https://www.nytimes.com/2017/06/11/health/vivitrol-drug-opioid-addiction.html
"As health secretary, he said, he had to call a meeting to tell Alkermes to “back off talking down methadone and buprenorphine” to legislators as the company aggressively lobbied to get Maryland to use Vivitrol.
“They’re exploiting a stigma that exists out of a very narrow view of their own economic self-interest,” he said. “And the result is going to be more people dying if they cannot get access to effective treatment.”
darn you're good at unearthing gold in the news feed...
Vivitrol as an opioid antagonist, poses a problem w/managing pain...so you get a monthly injection & have accident or surgery... stuck
re: buprenorphine “crutch” metaphor…I use it in my practice for those who refuse medication.. “so if you fracture your leg would you not have a cast to promote healing, would you not use a crutch? ... how's that gonna work out?”
Ultimately in opioid addiction recovery one strives for function w/out any crutches as healing takes hold .. yes insulin is required to manage chronic diabetes.. but life changes in diet & exercise can significantly modify that chronic condition making insulin injections unnecessary ….medication is vital to stabilize a patient so they can themselves embrace recovery and make life changes that require hard work... unfortunately Alkemes is targeting law enforcement officials by banking on their lack of understanding and their bias to deploying “non-addictive” medication as the solution; to promote chemical restraint in the form of an antagonist vs a partial agonist... my field experience tells me there is a high relapse rate in those mandated to take this as a condition of parole or court diversion process.. no research available yet I gather… Gotta hand it to Alkemes … good targeted marketing to the controllers of the purse strings; what’s TTNP mgmt done lately in the research department? …There is space in addiction Tx for both buprenorphine & naltrexone…. 2 different interventions for 2 different stages in recovery; apples and oranges… the treating professional in collaboration w/the patient can only make the decision if the treatment is to have lasting benefit …... now I remember back in the day, Medicaid did not cover Vivitrol.. didn't cover suboxone either for that matter...(the ACA changed all that) so in those states that plan to curb Medicaid expansion, who will pay for this antagonist, particularly if research reveals a statistically significant relapse rate in those mandated to take Vivitrol.. BTW anyone have any idea where TTNP is on the pain indication for probuphine?
no no no.. you are far from insane .. my reference to Einstein's definition was specific to investor's perception of TTNP management doing the same thing over and over without change... I note you are also looking at management w/a jaundiced eye..
I do agree that Probuphine is a challenge BC of the regulatory hurdles.. but I think Clean Slate has a chance of success.. though, again the uncertainty over ACA (Anthem pulling out of Ohio) casts a cloud over the market... no cloud even in sight in California... 6th largest economy in the world and we're going our own way ... sizable opportunity for Clean Slate & Braeburn.. the tack w/insurance companies is to demonstrate the cost-effectiveness of treatment w/MAT as opposed to ER admissions for OD, over and over again... every 1st responder Naloxone intervention probably bills > than 2G & ER visit can bill between $10,000 to $30,000... it's < expensive to pay for evidenced based treatment... the faith-based programs are laudable but incomplete..search news ~ the social model treatment(no meds) facility in PA where 2 "counselors" were recently found dead from an overdose
As far as Proneura is concerned, TTNP has no time to waste as the patent expires June 2024 AND inventors will be nipping at their heels w/new implantables... that's why I'm advocating a management change sooner rather than later.. I'm still hanging on as I see some value here.. but I am keeping a close eye on the landscape.. thank you again and again for your postings
agree.. the promise of Proneura platform is compelling .. but agree also w/other investors who have voted w/their feet that TTNP management has no track record of success, except to burn through other people's $ ... Einstein's definition of insanity "trying the same thing over and over again and expecting a different result" is often quoted in treatment w/addicts, stressing the need for change... as always, appreciate your insight..
the treatment centers are gearing up .. this will bear fruit for MAT in the long term... this term there were challenges w/insurance, pharmacy access, etc that made it difficult for a smooth roll out to small proprietors (TTNP's & Braeburn's initial strategy)... remember Clean Slate is one such small proprietor (1 MD) who had the vision to assemble scale in MA.. the rest of the facilities are still being rolled out, no doubt w/Apple Tree funding (I am encouraged by their model & scale)... injectables & implantables are not a quick answer alone to treating opioid addiction... successful treatment is complex... for example some people on methadone maintenance also take opiods on top of their allotted methadone (sometimes called "chipping", for a variety of reasons)... difficult to detect in standard field urinalysis.. no chemistry grad student knows more about how to mask a dirty UA test than a determined addict... ultimately the metric is going to be how effective is any combination of interventions in maintaining a patient's ability to function: get & keep a job & successfully provide for food clothing shelter... bottom line, Braeburn's S1 revealed many challenges to marketing Probuphine & given TTNP's weak management record, investors sold.. I'm hoping for a buy out or for the TTNP Board to wake up & press management to perform or fire management... that's their job..oh that's right they're not doing their job either .. well that answers that... Braeburn needs success (revenue) to IPO.. that's the hope for TTNP shareholders; that Braeburn will do whatever they can to make that happen
Apple Tree’s Clean Slate Treatment for MAT… great model for Probuphine numbers if they roll it out quickly & concentrate on the most populous states .. currently …36 facilities in 8 states; 13 of which are in Massachusetts w/a coverage of 1 facility for every .5 million residents.. why such a concentration there when in FL they have 3 facilities w/a coverage of 1/7 million & in TX 5 facilities w/a coverage of 1/6 million? the CEO lives in MA & started the franchise ~ 2009… outside of MA, their coverage is currently thin… in 2 of the most populous states, CA & NY, they have 0 facilities.. Sunil, Rubin & Bebe should convert the TTNP headquarters in CA into a Clean Slate Tx Center and work as free consultants .. that’s the best use of our capital right now… otherwise their tenancy is wasted rent space
Braeburn needs cash.. they need to IPO ... Apple Tree has sunk a hunk of change in Probuphine but their launch strategy ...training individual providers was never viable given all the regulatory hoops these small guys had to go through to prescribe this surgical implant... only hope is their addiction centers, courting the VA, large HMO's like Kaiser, County facilities, etc.... they have little choice but to continue to push probuphine & demonstrate some traction in order to IPO and get a cash infusion.. that being said, TTNP stock continues to be sold as there has not been any management change in this poor company ... at least Braeburn is shaking up management.. what a difference it makes when investors have their own money at risk as opposed to other people's money (like TTNP).. no pressure on the TTNP board to change one employee in an under performing company...BTW here it is June... where's the NDA for PD.. they said by June..... underpromise and overdeliver is basic MBA stuff.. they should have filed in May.. but again, why should they put themselves out, maybe work weekends? naw they've overpromised and underdelivered for years w/ no adverse consequences... their paycheck still flows .. classic operant conditioning.. continue to do nothing and be rewarded w/food.. why change?