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No time limit. He doesn't even have to do it if he changes his mind.
Accelerated approval is unlikely, but if a national emergency is declared you never know. It would be approved immediately subject to post-approval Phase IV trials.
Interesting, this guy is advocating the US Gov't assert its rights in probuphine and "nationalize" it to lower the price. It would probably increase sales, and Titan would still get a royalty, so I'm all for it.
This is a medication which has been proven to be effective. The government can use its existing rights to expand access and affordability. Earlier this month, President Donald Trump said that he would declare the opioid crisis a national emergency, and the President’s Commission on the opioid crisis recommended expanding access to medication assisted treatment in its report. Action on expanding access to Probuphine is one important tool which the government already has at its disposal.
https://www.keionline.org/node/2860
If and when the President finally signs the paperwork to declare the opioid epidemic a "national emergency," Braeburn should, in my opinion, file for accelerated approval of an sNDA for probuphine for chronic pain, and publically announce the filing to put heat on the FDA. They have the clinical marker necessary from the NDA already approved.
My understanding is the basic technology itself has been around a long time and is in the public domain. New patents can be issued on applying that known technology to new applications (that's how Titan got the Parkinson's patent).
Thanks Turks!
I'd love to see one of these testimonials come from Clean Slate. They have 32 centers now, and are owned by Apple Tree, so why aren't they using probuphine more?
The cool thing is that a ropinirole implant would provide the therapeutic agent and, through controlling titration, eliminate the need for a second drug to control the dyskinesia. But to your point..."What Me Worry" Bhonsle is not the dude that's going to get it done.
The thing being missed in probuphine's slow ramp up is Pro Neura's potential. Agree with others that this management team is not up to the task of capitalizing on it; I just wish the board did their job and made them do the right thing and at least look for potential buyers.
Yeah, $200 million in loss carryforwards would equate to $80 million with a 40% corporate tax rate. So, at today's price, you could buy Titan for $40 million ($1.50) and pay for it with the remaining $40 million of your tax savings.
What would you pay for this pipeline? All except oxytocin would be 505(b)(2) abbreviated approval processes.
Buprenorphine for Opioid Dependence: Approved
Buprenorphine for Chronic Pain: Ready for Phase 3
Ropinirole for Parkinson’s: Phase I
T3 for hypothyroidism: Ready for IND
Piperaquine for Malaria: Pre-Clinical
Liraglutide for Type 2 Diabetes: Pre-Clinical
Oxytocin for Autism: Pre-Clinical
You'd think Sunil and Rubin would buy 10,000 shares or so at these levels just to show support. It would help. The lack of insider buying at these levels seems to suggest to me that something is cooking that prevents it...material inside information, etc. Could be EU deal, could be partnership or could be buyout. You never know.
Liraglutide (Type 2 Diabetes) apparently works well in preclinical studies as a depot formulation (with actual advantages over daily injection dosing), so it should work just as well as an implant. Titan is doing preclinical work on it now.
https://www.nature.com/articles/srep31593
That's pretty cool.
From your keyboard to God's ears....I'd take a buyout.
Braeburn
Layoffs in July? Anyone heard anything about this. Hopefully getting rid of underperforming sales people.
http://www.cafepharma.com/boards/threads/layoffs.610361/
Looks like they are doing the trial in 4 phases which will string it out. Testing one rod first for 3 months on 5 people, then two for three months...etc. up to 4 rods. So no results for a year.
Maybe this will allow doctors to prescribe 1 to 4 rods depending on the patient's need. Not sure. But I don't see why you wouldn't do all the tests all at once...maybe a safety concern?
Yeah, I was right about the # of patients, but on the clinical trials.gov page Titan is estimating results by October 2018. I hope they are just trying to underpromise and overdeliver. I would think this could be wrapped up in 6 months.
Nice to see this posted so quickly...
https://clinicaltrials.gov/ct2/show/NCT03250117?term=Titan+Pharmaceuticals&draw=1&rank=1
Congratulations, you timed this well. I really thought probuphine would be adopted much more quickly, but...live and learn. From this bagholder's perspective....
I hear you on uncertainty regarding dilution, but with the recent loan facility, Titan is funded through 2018. That will get them through the Phase 1/2 for ropinirole (probably done 1H 2018), at which point I would guess they will partner out for Phase III, hopefully with some sort of up front payment.
Malaria was a nice surprise. The government is funding the whole thing, and so it should not have any affect on dilution.
T3 will be interesting. They have a pre-IND meeting this quarter with the FDA, and so we should know something more by the end of the year. By far the biggest market, with a big potential (15% of a 12 million person market (representing those who cannot convert T4 to T3). If T3 can be used as a monotherapy, the market goes to 12 million. Oral formulations require T4 to convert to T3, and so I'm hopeful there will be some benefits to the implant we haven't heard about yet. I know someone taking T3 and it involves multiple dosing per day, with fatigue setting in as the drug moves out of the therapeutic window.
Well, I was hoping to be cashing out on those probuphine sales right about now, but it looks like I'm stuck. It's humbling. Live and learn I guess.
Titan has enough cash to last through 2018, so I don't think they are too worried about the stock price. That's fine with me...I'm in it for the long haul...but the infuriating thing is a management team that continues to screw up and is accountable to no one.
The government is paying for all the testing...phase 1, 2 and 3. And the customer base is not just US armed forces, but those of our allies as well.
It is the type of item I would assume you need to keep in stock "just in case."
A better story than I thought, but no one knows about it.
Malaria
Geez...you'd think they'd let people know this is available.
http://c.eqcdn.com/_77c227ca8585bb2050dcd2be8d56a44a/titanpharm/db/341/1185/pdf/WRAIR+Poster+APMHE+2017.pdf
Well, probuphine isn't approved for pain so it doesn't help TTNP right now.
FDA more than a week late on the Parkinson's response. I'm hoping they didn't screw it up again.
It's your tax dollars at work. Once they put the clinical hold on, Titan can't proceed until they get the OK from the FDA. August 13th was the target response date, but there is not a requirement they meet the target.
It's 30 days after the initial filing, but if you've been put on clinical hold you have to wait for actual confirmation from the FDA.
If you look at how Braeburn has used 505(b)(2) as an example, they would do a limited Phase 1/2 for dosing/safety (maybe 20 patients), and then follow up with two Phase 3's (50 participants for each), one for efficacy and one for safety. Zacks's timeline is approval in late 2019, which would mean NDA submission late 2018 or early 2019.
On the type 2 diabetes, I just thought it interesting they called it out again and said they would only focus development on drugs where they could have a partner/funding from the outset. Victoza is a 3 billion drug that just went off patent, so I would assume Novo Nordisk would be interested in a way to extend patent life...maybe through Pro Neura.
Also nice to hear that the government is fully funding the malaria study. So if it goes to the FDA, the government pays the bill. Nice deal if it works.
IND submission won't do much for the price right now in my opinion. We are stuck down here for awhile.
We will see...other than the declaration of a national emergency, the Commission recommended the following...I've highlighted those items I believe could directly help Titan.
Grant waiver approvals for all 50 states to quickly eliminate barriers to treatment resulting from the federal Institutes for Mental Diseases (IMD) exclusion within the Medicaid program.
Mandate prescriber education initiatives with the assistance of medical and dental schools across the country to enhance prevention efforts.
Immediately establish and fund a federal incentive to enhance access to MedicationAssisted Treatment (MAT).
Require that all modes of MAT are offered at every licensed MAT facility and that those decisions are based on what is best for the patient.
Partner with the National Institutes of Health (NIH) and the industry to facilitate testing and development of new MAT treatments.
Provide model legislation for states to allow naloxone dispensing via standing orders, as well as requiring the prescribing of naloxone with high-risk opioid prescriptions.
Prioritize funding and manpower to the Department of Homeland Security’s (DHS) Customs and Border Protection, the DOJ Federal Bureau of Investigation (FBI), and the Drug Enforcement Agency (DEA) to quickly develop fentanyl detection sensors and disseminate them to federal, state, local, and tribal law enforcement agencies. Support federal legislation to staunch the flow of deadly synthetic opioids through the U.S. Postal Service (USPS).
Provide federal funding and technical support to states to enhance interstate data sharing among state-based prescription drug monitoring programs (PDMPs) to better track patient-specific prescription data and support regional law enforcement in cases of controlled substance diversion. Ensure federal health care systems, including Veteran’s Hospitals, participate in state-based data sharing.
Better align, through regulation, patient privacy laws specific to addiction with the Health Insurance Portability and Accountability Act (HIPAA) to ensure that information about SUDs be made available to medical professionals treating and prescribing medication to a patient. This could be done through the bipartisan Overdose Prevention and Patient Safety Act/Jessie’s Law.
Enforce the Mental Health Parity and Addiction Equity Act (MHPAEA) with a standardized parity compliance tool to ensure health plans cannot impose less favorable benefits for mental health and substance use diagnoses verses physical health diagnoses.
Trump says he will declare opioid crisis a ‘national emergency’
'We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,' Trump said Thursday.
http://www.politico.com/story/2017/08/10/trump-opioid-abuse-national-emergency-241493
Trump says opioid crisis is a national emergency, pledges more money and attention
https://www.washingtonpost.com/politics/trump-declares-opioid-crisis-is-a-national-emergency-pledges-more-money-and-attention/2017/08/10/5aaaae32-7dfe-11e7-83c7-5bd5460f0d7e_story.html?utm_term=.ce2d6317b163
Wow! Thought there was no hope for that after earlier this week.
Blah, Blah, Blah...
Not much came from the call.
They should know this week whether the FDA gives them a thumbs up on the parkinsons IND. If thumbs up, they are ready to start enrolling in September. It's now characterized as a Phase 2 trial, so they are skipping Phase 1.
EU partner by the time the marketing application is filed. My sense tells me no cash upfront on that one (US sales haven't justified it)...maybe a modest payment on EU approval.
Only thing I found interesting was they are focusing further development efforts on drugs where they could have a partner/research funding on day one. They called out luriglutide for Type 2 diabetes, a non-insulin drug (Victoza) that just went off patent manufactured by Novo Nordisk (Danish company, $109 billion market cap). That would be a nice deal.
They should hear by the weekend. As to PR's, who knows.
So the FDA "response date" on ropinirole is August 13th.
By law, the FDA has 30 days to respond from the date of submission.
Which means Titan gave the FDA the requested info on July 14th, two weeks later than promised.
White House rejects appeal to call national emergency over opioid epidemic
https://www.statnews.com/2017/08/08/opioid-epidemic-emergency/?utm_content=buffer87ee1&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
Timed the announcement to when Christie was out of the country...
It was a total nonevent anyway. Trump is just kicking the can down the road.
Trump to hold ‘major briefing’ on opioid crisis
https://www.washingtonpost.com/politics/trump-to-hold-major-briefing-on-opiod-crisis/2017/08/08/8b7cd146-7c2f-11e7-9d08-b79f191668ed_story.html?utm_term=.646ab7ed17a8
My bet is he will announce a federal state of emergency today.
Trump shifts to opioid crisis
Major announcement today at 3pm held in N.J., Christie's home state.
Hmmm
http://thehill.com/homenews/administration/345690-trump-shifts-to-opioid-crisis
President Trump, Declare An Emergency On The Opioid Crisis Now
http://www.huffingtonpost.com/entry/jeb-bush-dr-oz-declare-emergency-on-opioid-crisis_us_5988d65be4b08a4c247f2507