Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Anyone notice the paragraph right before the one Truth quoted. It read...
"High profits in the middle of this epidemic are really unconscionable," she says.
Sheldon, of Braeburn Pharmaceuticals, says the company will offer rebates to make sure appropriate patients can get access to the implant. She plans to negotiate with insurers and providers on a price that takes both their cost and savings into account, she says.
"And if they don't realize those savings, we're happy to rebate them even further," Sheldon says.
So Braeburn plans to negotiate with insurers, pricing probuphine based on their potential savings...a return on investment argument. If they don't realize the savings, a sales credit/rebate? That speaks volumes. What other drug company basically guarantees that an insurer will realize cost savings?
Now that "Societal Outcomes" study (showing a 80% reduction in rehab, 97.0% reduction in accidental ingestion, etc.) makes sense.
Amen to that! I don't think they are signing up for some pretty rigorous training (with a certification test) just to get the free tee-shirt!
By the way, speaking of Higgins I noticed that he is now working for Roth, and was one of the hosts of "Roth's Pharmaceuticals Corporate Access Day" that Titan attended yesterday.
I've always thought his 2014 research report was very thorough, and it would be really interesting to see if his views on Titan had changed.
Good article, but the inference created is that probuphine will be priced close to vivitrol ($1,000 a month) which I don't believe is true.
Based on Michael Higgins Highline research report in 2014, I assumed the cost of treatement was around $2,000 for six months. Of course, in light of the increased demand Braeburn might determine that they can increase that somewhat without adversely affecting sales. But I don't think the cost of probuphine treatment is going to be anywhere around $12,000 a year.
New Investor Presentation
Primary differences from the March presentation that I noticed were as follows:
1. At page 13, in the description of efforts to explore commercializing Pro Neura for other chronic diseases, they removed the bullet point at the end of the page reading "Benign Prostate Hyperplasia, Pre-exposure prophylaxis therapy for HIV-1 prevention, Type 2 Diabetes, Attention Deficit Hyperactivity Disorder”
Unless they have stopped exploration efforts (which I doubt), there isn't any justification for the removal. Unless they have signed a nondisclosure agreement with a potential pharma partner which states they are not allowed to comment at all on the subject matter of the nondisclosure agreement.
2. At page 17, in the discussion of the ropinrole implant, a bullet point in the March presentation read "On target to file IND in Q4 2016 followed by the initial pharmacokinetic and proof of concept clinical study." In may, this has been broadened to two bullet points reading:
"Commenced non-clinical toxicology evaluation of the ropinirole implant" and "On target to file IND with the initial pharmacokinetic and proof of concept clinical study in Q4 2016."
Good news, because since March they have commenced the toxicology evaluation and appear to be committing the the Phase I proof of concept study in Q4.
I kinda think this retracement is the shep-heads following their Beloved Leader.
If approved, I just might do that. Off label usage cannot be marketed, but the approval process for animal drugs isn't anything like the difficulties you have for humans (the FDA actually approves animal drugs also).
http://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm219207.htm#The_End:_The_Puzzle_is_Complete
Even if Titan doesn't want to pursue it (which they probably wouldn't), why not sell the rights for animals or at least out-license it? I mean, let's get creative here.
Good riddance!
Don't laugh, but when it comes to the off label potential of probuphine, who says Titan is limited to humans? Non-human usage wouldn't be covered by the Braeburn license, and so all the profits conceivably go to Titan.
One rod probably cost 25% of a full treatment ($500). A grand a year to make Fido feel better in his old age, and you don't have to shove a pill down his throat every morning?
I'd say there are 20,000 rich dogs out there that could use the pain relief. $20 million in pure profit.
Just saying....
http://www.diamondbackdrugs.com/buprenorphine-for-veterinary-use/
WHO KILLED PRINCE? RESTRICTIONS ON BUPRENORPHINE
https://jebkinnison.com/2016/05/17/who-killed-prince-restrictions-on-buprenorphine/
The title is a little questionable, but an interesting take on the history of probuphine in this blog
Thus the need for a drug delivery system that didn’t allow for easy diversion or abuse, and delivered a constant dose of the medication without requiring the patient to remember to take it. Titan Pharmaceutical’s Probuphine, an implantable form of buprenorphine, started development in 2000, was rejected by the FDA in April 2013 for what appear to be murky reasons, and is up for approval again in 2016 after a three-year delay to gather more data to answer FDA questions. The episode looks like an instance of Bootleggers and Baptists overregulation, with vested interests blocking a much-needed new drug implant to protect their interests while throwing up a cloud of “concerns” to justify their actions.
Titan began development of the drug implant in 2000 after licensing the patent from MIT in 1996. At the beginning of development, buprenorphine was approved and in use for anti-addiction treatment in France and Australia, but was awaiting more studies and FDA approval in the US. When the FDA approved buprenorphine tablets in 2002 under the then-new law allowing opioids to be prescribed for addiction treatment, Titan appeared to have a winning idea on its hands after the DEA and FDA soured on the bright early hopes for tablet-delivered buprenorphine — Titan’s implantable form would address all of the issues that so concerned the DEA and improve success rates among addict populations.
But the FDA rejected Titan’s application in April of 2013 despite the positive recommendation of their panel of outside medical experts, a rare event. The company’s stock dropped by 80%, typical when a small drug company’s key development project is rejected. One biotech publication outlined the FDA’s position:
In the end, a vote by an outside panel of FDA experts favoring approval of Titan Pharmaceuticals’ Probuphine didn’t influence the outcome at all. Agency staffers stuck with the opinions outlined in a harsh internal review and rejected the opioid addiction drug, outlining some extensive demands for new clinical data that would be needed for an approval.
In a statement, Titan ($TTNP) outlined three key requirements on new efficacy data. Titan will have to offer clear evidence of:
• The ability of Probuphine to provide opioid blockade of relevant doses of agonists.
• The effect of higher doses of Probuphine, ideally doses more closely approximating the blood plasma levels associated with sublingual doses of buprenorphine of 12 to 16 mg/day.
• Human factors testing of the training associated with Probuphine’s insertion and removal.
The FDA’s panel had voted 10 to four in favor of an approval, but the agency had no problem overlooking the majority support along with Titan’s claim that Phase III data demonstrated that Probuphine, an implant that releases buprenorphine over a period of 6 months, was better than a placebo at preventing addicts from using illicit opioids. Investigators also said it was noninferior to the approved therapy. But staffers picked apart that argument in the internal review.[8]
The outside panel recognized that while results were not perfect, Titan’s product was needed immediately and offered enough advantages over alternatives to merit approval. FDA staff decided to reject the drug and require several more years of studies and delays before looking at it again.
Remember, this is a widely-used drug since 2002, and the company had been at work on the required studies for many years before bringing it to the FDA for approval in 2013. The delay nearly killed the company and the implant product, and Titan was forced to sell rights to the drug to another company, Braeburn Pharmaceuticals, to get enough money to continue.
Because the FDA is an unelected, unaccountable bureaucracy, no one knows how often their decisions are swayed by politics and under-the-table influence-peddling. Doctors can be stubborn and view themselves as protecting the public, or require even more proof of efficacy, or perhaps can be influenced by communications from Big Pharma interests who might see opioid revenues decline if better treatments for opioid addiction became available. No one knows or can know whether improper influence occurred in this case — it’s best to assume erroneous belief, rather than corruption, causes this kind of damaging mistake.
Titan came back to the FDA with the requested new studies, and a hearing was held January 13, 2016. The Psychopharmacologic Drugs Advisory Committee again has recommended approval, this time by a vote of 12-5. But again, some panelists were against approval, working hard to come up with reasons to deny a new treatment to people with life-threatening addictions:
Probuphine works like a contraceptive implant, such as Norplant. Four implanted rods, each smaller than a matchstick, provide a steady amount of medication for up to 6 months. The FDA is considering approving it for a specific population: “stable” patients who are already taking the dissolvable buprenorphine film at a low dose. The committee voted 12-5 in favor of probuphine.
“I think this will save some folks’ lives,” said advisory committee member David Pickar, an adjunct professor of psychiatry at Johns Hopkins Medical School in Baltimore.
Doctors who want to prescribe probuphine would have to refer patients to providers trained to implant medical devices, or undergo training to learn how to safely implant and remove it, said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals, who spoke at Tuesday’s advisory committee hearing.
Implanting probuphine takes 10 to 15 minutes and removing it takes about 20 minutes, said Steven Chavoustie, a physician involved in a clinical trial of the device.
Pharmacist Tracy Rupp urged the committee to reject probuphine, noting that its manufacturer presented only one clinical study showing the drug was effective.
In the study, doctors compared the use of probuphine implants and buprenorphine film, Sheldon said. Patients in the study were considered “stable” because they had been safely using the films. After 6 months, 85% of those given probuphine tested negative for illegal drugs, compared to 72% of those given the film.
The study had multiple flaws, said Rupp, director of public health policy initiatives at the National Center for Health Research, a nonpartisan group that analyzes health data.
Some missing urine tests were counted as negative, as if the patient had no drugs in their system. But Rupp noted that people addicted to opiates “often skip tests to avoid a positive test.” That could skew the results, Rupp said.
“It is disappointing that the advisory committee set such a low bar for safety and effectiveness,” Rupp said after the vote. “Is probuphine effective? We still don’t know because the study was poorly designed and missing data.”
Judith Kramer, the committee’s acting chairwoman, said she voted against recommending probuphine’s approval because doctors don’t yet know if it’s effective for more than 6 months. Many people who are addicted to opiates need to take medication for years, she added.[9]
Notice the proposed use is now restricted to patients already on the film form of the drug, and the advantages—six months guaranteed compliance, for example—are ignored in favor of nitpicking, as if the efficacy of the drug itself has to be proven all over again. The goalposts have been moved. The FDA will rule soon, and may well reject the drug again despite the positive panel recommendation.
Yes, Zacks was left with a lot of egg on its face (and probably some angry customers) after 2013. There is not any downside to being conservative, so why wouldn't they.
Very informative. And maybe that's why TTNP did not go down the Type 2 diabetes route...they are looking for markets where Pro Neura fits a need, and there is not any other implant competition.
As you say, it's impossible to know how many of those trades involved opening up a short position or just market makers shorting to fill orders. However, the last reported Nasdaq short position of 1,170,000 shares is about as high as I've seen for Titan, and much higher than when the PDAC met.
I think a lot of the short positions are just technical in nature: a formula saying that a price that has risen so precipitously is bound to fall. Others probably figure that if the FDA was going to approve probuphine, it would have done so by now. I must admit the thought has run through my mind more than once (especially given the PDUFA date...if you're going to issue a CRL on a popular new drug, do it at market close before Memorial Day weekend). Unpleasant, illogical and downright infuriating, but it's a possibility. I laughed at them in 2013 after all.
We may see a lot of selling the closer we get to the PDUFA date as folks get jittery. Owning this stock has never been a carefree endeavor.
I just want to say, whatever happens next week, it has been a pleasure learning, exchanging ideas and investing with the posters on this board. I wouldn't hold it against anyone to cash out while they can. But as for me, it's damn the torpedoes....
It's frustrating. I understand why Braeburn insisted on confidentiality, but the fact that we have no understanding of how and when the sales milestones are paid out (other than Sunil's statement on the 4Q conference call that at $250 million in annual sales "nearly two-thirds" would be earned) makes any kind of meaningful forecasting very difficult.
In addition, we are just guessing at the price of the implants. Higgin's report assumed $2,000 a treatment, but I'm not sure where he got that from. What if its $2,500 a treatment, or $1,500 or $1,000?
Thanks for the current info...it's hard to find a good snapshot of where PE's are in pharma/biotech right now.
I forgot they were also not valuing the sales milestones (or regulatory milestones for chronic pain).
Geez.
By contrast, when Michael Higgins of Highline did his analysis back in the day they assumed a PE of around 40 and a dcf discount of 25%. Using Zach's numbers (including the 75% chance of approval), that would equate to a value of $23.62 per share.
Pretty conservative on their part...no value included for international probuphine rights, parkinsons, T3 or Pro Neura for other applications.
They say stock is worth $8.50 a share under dcf analysis that includes an assumption of a 75% chance of approval. So by implication if approval was guaranteed (100%), they'd value TTNP at $11.30 a share.
They assume 2018 eps royalties around $30 million (which implies sales of around $150 million) with eps in excess of $1 a share (let's say $1.10). Assuming a PE of about 20, that's about $22 per share in 2018, which means the dcf analysis is applying an additional 50% discount.
Anyone know who announces first, the FDA or Titan/Braeburn? If its a rejection, the company nearly always goes first, but I don't really know what happens with an approval.
Love the optimism Turks, I share it, it's just the market doesn't agree with us yet! I really have no idea what share range we will be trading at after approval. Pfizer just agreed to pay Anacor $5.2 billion for an eczema gel, so who knows.
I hope you're right about an early approval this week catching shorts off guard, but if they've delayed this long my gut tells me they will take it up to the buzzer (May 27th).
I tip my hat to you sir.
That certainly could be the case, although they've had the trial data for nearly nine months now. I tend to think whatever REMS issue the FDA requested information on has been dealt with (the REMS was approved before the PDAC meeting after all), and its down to labeling.
They could throw us a curveball and completely ignore the rulebook and say that although probuphine is not inferior, it is not "superior" enough over SL buprenorphine and more testing is required. To my mind, such a negative decision would be "arbitrary and capricious," allowing Braeburn to appeal the ruling (as Vanda did with Fanapt in 2009). I think that is unlikely, but given the FDA's history, it is a possibility. And that possibility is why TTNP is trading in the 5's.
Good Results on Buprenorphine Implant
Conference Coverage > APA 2016
May 13, 2016 | Gale Scott
http://www.hcplive.com/conference-coverage/apa-2016/good-results-on-buprenorphine-implant
Research to be presented May 17 at the American Psychiatric Association’s annual meeting in Atlanta, GA, should strengthen the case for approval of a buprenorphine implant known as Probuphine (Braeburn/Titan).
An advisory panel in January, 2016 recommended the US Food and Drug Administration approve the drug. The FDA has said it needs more evidence that administering the buprenorphine as an implant will not result in infections or injuries, problems seen with the birth control implant Norplant.
Reporting on a non-inferiority study at his institution, Richard N. Rosenthal, MD, MA, said results with the subjects in his study, a double-blind placebo, showed that after six months, patients who got the implants showed a 96.4% rate of staying off opioids, compared to 87.6% of those who took buprenorphine in the currently approved form, sublingually in pill or film form
Rosenthal is a psychiatry professor at the Icahn School of Medicine at Mount Sinai in New York City and Medical Director, Addiction Psychiatry of the Mount Sinai Behavioral Health System.
In an interview, Rosenthal said the study showed the implants were safe and effective. Patients who got the investigational drug had four rods the size of a matchstick inserted under the skin of an upper arm.
“Everyone did well,“ Rosenthal said.
The treatment requires four implants because a single one would be too large, he explained.
The patients in the study were all addicts who got hooked on prescribed opioid pain drugs, he said.
“It’s a very stable population,” he added.
He estimates that there are 1.9 million people in the US who could benefit from the implant, a method of treatment that does not pose a threat of drug diversion since it is administered in a one-time office visit rather than in a prescription that could be abused. Nor does it pose a risk of accidental poisoning to others, particularly young children in the addict’s household.
When buprenorphine first appeared on the addiction medicine scene in 2002 there were some concerns that addicts would not get the counseling and monitoring that is supposed to come with the directly observed therapy of methadone treatment. Early proponents of buprenorphine dismissed those objections and in turn accused the “methadone treatment industry” of trying to block widespread use of buprenorphine because of the financial threat to the clinics and counselors that have a vested interest in that treatment.
“That’s no longer a controversy,” he said, “methadone is still out there too.”
Buprenorphine can be given by a primary care physician, though these practitioners must receive training before they dispense it. One big advantage to patients is convenience and privacy. But that does not mean implant patients can safely see a treating physician for only the visit in which the drug is implanted. They need morcare than that, he said.
Rosenthal said that the current thinking, at least in his practice, is that “Any patient using opioids should be getting psycho-social treatment,” including patients say they accidentally got addicted to opioids through prescriptions--as opposed to addicts who sought the drugs out solely for recreational purposes. - See more at: http://www.hcplive.com/conference-coverage/apa-2016/good-results-on-buprenorphine-implant#sthash.ulPk8kX2.dpuf
Thanks for posting. This appears to be new (I'm sure it was requested by the FDA after the CRL)...no statistically significant variable (age, gender, demographics) predicted response in either probuphine or SL buprenorphine. Good, because such a varied response based on age, gender or demographics in probuphine but not SL buprenorphine could have been an excuse for more study before approval.
PREDICTORS OF RESPONSE OF A COMPARATIVE TRIAL OF SIX-MONTH BUPRENORPHINE IMPLANTS AND SUBLINGUAL BUPRENORPHINE IN STABLE OPIOID DEPENDENT PATIENTS
Lead Author: Richard N. Rosenthal, M.D., M.A.Co-Author(s): Michelle R. Lofwall, M.D., Sonnie Kim,
Pharm.D., Michael Chen, Ph.D., Katherine L. Beebe,Ph.D., Frank J. Vocci, Ph.D.
SUMMARY:
Background: A recent multicenter, double-blind, double-dummy, non-inferiority trial compared six month buprenorphine implants (BI) to daily sublingual buprenorphine (SLBPN) among 177 stable outpatients maintained on 8mg or less of SLBPN. The primary efficacy endpoint was the proportion of responders (at least four of six months without evidence of illicit opioid use by urine test and self report).
The responder rate was 96.4% for BI and 87.6% for SLBPN (difference=0.088). The 95% CI for the rate difference (0.009, 0.167) demonstrated non-inferiority. Statistical superiority in favor of BI (p=0.034) was also shown. This poster reports on a number of post hoc analyses assessing potential predictors of clinical response in both treatment arms.
Methods: Post hoc analyses were conducted with the intent-to-treat sample to determine if any baseline demographic or clinical factors such as age, gender, primary opioid of abuse, sublingual buprenorphine dose and use of supplemental buprenorphine predicted response to treatment.
Results: No variable was statistically significant as a predictor of response in either treatment group. There were trends toward increased response effect (0.242, p=0.08, 95% CI [0.048, 1.21]) in the BI group among participants older than 36 years and a female versus male effect (7.42, p=0.0625, 95% CI [0.09, 62.06]) There were no trends in the SLBPN group.
Conclusion: Although the study was not powered to detect predictors of response, the results are consistent with previous reports among opioid dependent samples receiving buprenorphine formulations, suggesting that older age is a positive predictor of treatment response. This research was supported by Braeburn Pharmaceuticals.
The 1,170,000 shares short number was as of April 29th...I assume a lot more short positions have been initiated since that time. In the words of the first great Wall Street operator, Daniel Drew,
"He who sells what isn't his'n
Must buy it back or go to prison."
http://www.nasdaq.com/symbol/ttnp/short-interest
TWO WEEKS....We've been standing in line for ever. In two weeks, we see if they let us on the roller coaster, and then the ride really begins.
For anyone who gets nostalgic about past root canals, you can relive the fun of the Ad Comm at the FDA site. Interesting excerpt from the presentation of Beshad Sheldon (Braeburn's CEO):
"As we've reached agreement with the FDA's Division of Risk Management on the proposed REMS, we are providing this overview of the REMS on behalf of FDA as well."
So not only had the FDA agreed to the REMS in advance of the meeting, they allowed Braeburn to give their presentation for them. But a REMS issue comes up that delays the PDUFA? Too weird.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM500364.pdf
I wonder how current those numbers are? I assume a lot of shorting in the drop from the $6's between May 4 and May 6...it would be interesting to know if those short positions were included.
It's actually a little worse for the shorts...the float is 16,180,000 officially (basically 20 million less the Braeburn and Broad Fin shares), but remember old Robert Mead owns 1,355,000 shares and he seems to be in for the long run. Plus Nasdaq's institutional ownership reports state that, excluding Broad Fin, about 1,100,000 are held by institutions that may not be likely to immediately sell on an upswing.
16,180,000 minus 1,355,000 minus 1,100,000 equals 13,725,000. The 1,170,000 short positions represent about 8.5% of the revised total.
I think so...I thought all buprenorphine was Schedule III.
Very interesting thought, and it could explain why there has not been a early approval. Although all things being equal, I will take Dr. Young and his experience on how things work at the FDA.
Not to count our chickens before they hatch...
...but why wouldn't probuphine for chronic pain get a similar fast track designation...
http://finance.yahoo.com/news/kempharm-receives-fast-track-designation-123000546.html
Favorite Exchange From Conference Call
I seem to remember Kate Beebe saying "chomping at the bit" instead of "jumping at the bed," but you get the point...
John Vandermosten
Okay. And this point ProNeura has only been used with generic products. And I’m wondering, if there’s, or there might be any opportunities for any on patent products out there that might be helped with this technology, is that something that might be pursued?
Sunil Bhonsle
Absolutely, John, and it’s a very good question. And when you think of ProNeura and its basis for treatment basically providing a state-level of drug long-term typically something that is available only through IV therapy in hospitals that is somewhat restricted. And something like a ProNeura implant, which can provide that same benefit, while you are not restricted in a – in hospital setting is a major advantage.
And obviously, our first products have been in areas where there is already proven efficacy that provides a basis to show this technology works and we believe we’ve done that with Probuphine. We’re now moving into the next two products both of which have a lot of promise, but once again, they are both products based on compounds that already have shown to be effective.
Our next step really is to expand that both with drugs that are known to be effective and offering this technology as a basis for development of other products that are proprietary to other companies. And this includes products where potentially they see problem such as for as fast [ph] metabolism, which we can avoid by delivering a drug in this manner, that types possibly that are not easily delivered orally can be delivered in this manner.
So there are many opportunities. And our goal now and strategy starts expanding to include these opportunities by working with other companies who have proprietary compounds. Kate is looking forward to that very much.
Katherine Beebe
Yes, I’m jumping at the bed.
Agreed. I bought Titan because probuphine just really made sense to me for addiction: I have some life experiences in that area that have shown time and time again the power of that disease, and the inability of human willpower to conquer it. I see now that I really couldn't see the forest from the trees. And so I have focused rather singlemindedly on efficacy and the addressable market of patients requiring 8mg of buprenorphine per day, while kind of giving a shrug to the implant technology itself. It doesn't look all that impressive after all, just a thin little polymer rod. But it revolutionizes the way drugs are delivered. For me, it really crystalized it on the conference when Sunil described it as being indistinguishable from getting "hospital level IV care."
My understanding is that the primary limitation is the size of the molecule being administered: ProNeura requires relatively "small" molecules that may rule out some drugs. However, as you said, there are a multitude of possibilities...small molecule plus issues of compliance or titration=opportunity. Schizophrenia for example (Braeburn has its own implant for schizophrenia that will have to go through rigorous testing). Titan's delivery system hopefully will be cleared by the FDA after the end of this month, so the only real question will be whether it can deliver are therapeutically significant dosage.
I'm not really a TA type investor, but I've run what this guy says against actual approvals I've experienced and it pretty much runs true. I think there will be chances to buy in at attractive prices (and much less risk).
http://thepatternsite.com/fda.html
Congratulations on the new house! That's awesome, and you totally made the right decision. Nothing is guaranteed on this one, and by selling you can actually say you've profited on Titan (my paper profits could go up in smoke in a heartbeat after all).
I think if I ran Braeburn I would buy Titan. And so I've speculated before that Braeburn will buy them, because I blindly assume they think like me. But I'm a little crazy, and they are not. I will guarantee you the people that run Braeburn don't invest in OTCBB stocks (like Titan was when I bought in). They are also playing with other people's money, and so if they make a mistake they are out of a job. I don't think they are comfortable with the risk of a flop, otherwise they would have bought it already (they could of had it for a song a year ago). So I think they will probably take a wait and see approach, realizing it will take years to reach peak sales. Plus, Braeburn seems to be more interested in partnering with companies that have drugs pretty close to approval. Buying Titan now is buying ProNeura...promising as all hell, but neither Parks or T3 is even in Phase I yet.
My optimism in Titan long-term is unabated. I think probuphine will be a success (and more importantly save lives), but its clearer to me now that the real story is the delivery mechanism. ProNeura is pretty revolutionary, and the talk today of partnering with other pharma's with patented drugs that could benefit from ProNeura is really exciting.
I think we will get a pop on approval (PLEASE GOD!), and then continue to increase by about 50% above the closing price on the date of approval as institutions buy in. There will be a natural retrenchment and the price will drop as we are no longer the flavor of the month, and there will be new buying opportunities. Then it comes down to sales and events (ROW deal, new partnerships, Parks, T3, chronic pain). Plenty of spikes and drama, and plenty of chances to buy in.
Somebody much bigger than Braeburn might fall in love with ProNeura and buy Titan out at any time. But I don't think it will be Braeburn.
Yes, Sunil said something to the effect that Kate Beebe was "chomping at the bit" to get started on patented medicines, which suggests maybe they are in discussions with someone.
Sunil stated they were "comfortable and confident" about the FDA review process. They plan on expanding Pro Neura to proprietary, on-patent drugs (they've only worked with generics thusfar). And they acknowledged that Braeburn was interested in chronic pain, but wouldn't detail timing.
...I mean, you don't just reimburse expenses unless you are contractually obligated to do so. And they weren't obligated to do so until FDA approval had been obtained.
I hope you're right! Despite all the hoopla in the press, I really don't think approval has been priced into the current share price (I actually think the price is discounted based on the 2013 CRL).
Although I don't believe we will experience anything quite as dramatic, VNDA in April of 2009 is illustrative of what can happen to a small pharma with no approved drug on approval. It went from $1.08 to $14.00 in a matter of days...different situation in that everyone had written Fanapt off, but still there are some similarities and they had a similar number of shares outstanding.