Actually, the linked article indicates schizophrenia application was the first target for Pro Neura, but that program was put aside in favor of opioid abuse. Sunil mentions that he's still interested in pursuing it, but I assume that would be in partnership with a Big Pharma (perhaps a proprietary compound rather than a generic). A lot of it has to do with molecule size of the drug in question...the smaller the molecule, the better it works for Pro Neura. I know Braeburn is pursuing a risperidone implant for schizophrenia, for what it's worth.

Truth has mentioned in the past that buprenorphine has shown positive results for severely depressed people with suicidal thoughts...a situation where an implant (probuphine) would be highly advantageous.


http://www.thedailybeast.com/articles/2016/03/27/can-an-implant-stop-heroin-addiction.html

Agreed...how about an explanation of exactly what preclinical testing is being undertaken at the FDA's request in support of the parkinsons' IND, and the status of that testing. The FDA could learn a thing or two about moving the goal posts from Titan's management, who constantly move goals backwards in time and describe it as "being on track."

On sales, they always defer to Braeburn, but I seem to remember that Titan has the contract with the third party manufacturer of the rods (not Braeburn). So until Braeburn builds its own facility, they should be in a position to know how many rods have been ordered and there is nothing in the license agreement with Braeburn that would prevent them from letting us know. But, I'm not really sure on how the entire supply chain relationship is structured (I could be wrong), which only points to how little they disclose.

I really don't think they've done anything at all on a ROW deal. Sunil bought shares recently, which is notable in that (1) for most public companies, buying or selling of shares is forbidden during the "quiet period" between the end of a quarter and the release of earnings, and (2) we must assume that, in order to comply with federal securities laws, he was not in possession of any material nonpublic information at the time he bought those shares. A ROW deal (or any buyout discussions) would certainly be "material nonpublic information," and so its logical to assume that nothing is happening on that front.

But their proxy statement asking for additional option shares to reward their performance was nicely done....

As of 7-15, short interest has decreased to 2,150,287 (it was 2,531,760 on 6-30). However, "days to cover" (based on average volume) has increased from 4.53 on 6-30 to 12.49 on 7-15. As volume lowers, the position of shorts begins to be very dangerous.

Well said! That's certainly where I'm at.

...I know it sounds crazy, but seriously they have a patent for probuphine issued in Mexico. Why not use it? Just sell to two or three high quality private clinics there and get 1,000 or 2,000 Americans or Canadians whose insurance won't pay for it to take a vacation and get an implant. I'm sure a US doctor could even remove the implant...why not?

OK, maybe I'm obsessing over a ROW deal.

Under the heading of diabolical ponderings...but business is business after all. Braeburn has the US and Canada. Some patients may be denied insurance coverage in the US or Canada, but still want probuphine.

How about Titan independently offering a South of the Border alternative? According to the link, probuphine could be approved in Mexico in 60 days. Offer it for a more affordable $2,000 a treatment (instead of Braeburn's $4,950), pay $500-$600 for the rod and keep $1,500-$1,600 in profit.

You sell a thousand treatments a year in Mexico that way, and bank $16 million in profit. You would need $100 million in sales from Braeburn (20,000 treatments) to receive as much in royalty payments.


http://www.loc.gov/law/foreign-news/article/mexico-directive-allows-sale-of-pharmaceuticals-previously-approved-by-the-u-s-fda/

Just curious, why would it only be two months for FDA review.

I've been assuming 30 days to meet with the FDA, another 60 days to plan the trials, two months or so for the trials and then another two months to prepare the resubmission followed by another six month review period (with an Ad Com likely as safety has been highlighted).

I realize it's not rational, but the FDA truly is the Queen of Hearts from Alice in Wonderland. They can change the rules at any time.

Psychologist...

You might remember that right after approval, a psychologist published an editorial that got a lot of press claiming probuphine would be a flop. The article got a lot of circulation, was picked up on yahoo news etc.

A new editorial was recently published in Psychology Today with exactly the opposite point of view...and no traction.

Man, I wish there was a way to track sales!

https://www.psychologytoday.com/blog/new-beginning/201607/substance-abuse-counseling-and-arm-implant-good-match

Truth: agreed. I want to hold to see where sales are after two quarters at least, which would mean the earnings announced in March 2017. But let's face it, I'm holding to measure Braeburn's progress, not Titan's.

With different management, we would have a ROW deal by now and have commenced a Phase I for parkinsons. But I'm not particularly hopeful on that front anymore; it could happen, yes, but it just feels more likely that it will drag out for years.

Maybe it's just me or perhaps frustration for holding for so long, but I don't sense any energy or "fire in the belly" coming out of Titan.

My gut tells me 0.15, but part of that is my ego compensating for the sting of being wrong about SequestOx, so 0.08 or 0.09 seems about right. Should be in the "Tweens" by the end of the week.

Understood. And there may in fact be legitimate reasons why the press release was so terse and uninformative. If not, the flaw may relate more to a bruised ego rather than disregarding stockholders. If I were in his position, I probably wouldn't feel anything but blind rage. I truly believe that as of the time of the conference call, everything seemed great with the FDA and he, like the rest of us, couldn't see the train coming. Makes it harder that as much as you would like to point out the flaws in the FDA's reasoning, you are going to have to deal with those people again if you want the approval. So you end up thanking them for their review. Stoop to conquer.

Anyone who tries to build something is going to fail at times, sometimes for reasons that aren't his fault but remain his responsibility. I hope NH, upon reflection, eats some humble pie and talks to us about what is going on.

Well, NH definitely had a worse 2 days than anyone on this board, I will agree with you there. But the press release was neither forthcoming nor straightforward. It's easy to play Monday morning quarterback and pick apart performance, yet one of the things NH has to worry about at this time is continued funding of the company. If he is going to do that through continued sales to LPC, then the price of the stock is obviously critical. And leaving stockholders no idea what is going on only leads to uncertainty, which creates fear...and we all know where that goes.

There is nothing preventing him legally from discussing the content of the CRL. If it's bad news, then so be it, let's get to the bottom quickly so we can begin the path upward rather than languish in doubt for months until he has had the opportunity to speak to the FDA.

I vote for option 2. Please!!!!

I'm going to lose some money on Monday, and so I'd like to put a positive face on this but I have to disagree. SOMX issued a very responsible post-CRL press release; ELTP did not, and that falls on its CEO.

Examples of wording in the SOMX CRL press release:

-The FDA did not specifically request the company to conduct additional clinical trials of Silenor.
-With respect to safety, the FDA noted that there were no adverse events observed in the clinical studies included in the NDA that would preclude approval, but asked the company to address the possibility that doxepin may prolong the cardiac QT interval.
-The company intends to respond by submitting to the FDA the results of its completed clinical trial of doxepin that evaluated the potential for electrocardiogram effects. As the company has previously disclosed, the results of this clinical trial demonstrated that doxepin had no effect on QT interval prolongation when administered at 6 mg or 50 mg.

http://www.businesswire.com/news/home/20090226006132/en/Somaxon-Receives-Complete-Response-Letter-FDA-Silenor%C2%AE

It wasn't a very thoughtful press release, nor respectful of stockholders.

Basically a "cut and paste" job

https://globenewswire.com/news-release/2016/06/13/848205/0/en/FDA-Issues-Complete-Response-Letter-for-Apadaz-New-Drug-Application.html


http://www.econotimes.com/FDA-Issues-Complete-Response-Letter-for-Mycapssa%E2%84%A2-New-Drug-Application-196078

Which makes the whole "we will update you once we talk with the FDA" thing a bit arrogant...if it's bad news (another Phase III), then it won't hurt the price any more than no news. But if its good (resubmission of NDA possible yet this year), it could really help out.

Hate to say it, but a lot of CEO's full of braggadocio and swagger run and hide when the bad news comes.

I'm hoping for a dead cat bounce to around .15, but I'd say below .10

Yeah, I just don't understand how everything was so hunky dory a month ago on the conference call (no problems, etc.) and then...a CRL.

I also suspect they had this yesterday and waited all day to release it. A bit cowardly in my opinion.

Disappointing all around, but the FDA can be a real heartbreaker.

Maybe its just me, but the press release was very cryptic, and a bit arrogant. Often, I've seen companies describe the reasons for a CRL (such as more data required, etc.). If this is a CRL over labeling, that's a lot better than a CRL calling for more clinical trials. I also think a CC before the market opens Monday might do more good than just saying "we'll get back to you" once we talk with the FDA.

Any thoughts on whether this pushes ELTP closer to a "hail mary" buyout? Another round of clinical trials would require much more further dilution, and management may decide they are better off handing over the reigns of development elsewhere.

Agreed, but in that case there is nothing stopping ELTP from issuing guidance that they haven't heard anything yet.

Instead, silence.

If that's true, it's a really good sign.

The FDA doesn't PR CRLs.

So if ELTP is waiting for a press release...

Fear and risk avoidance. And 3 million shares is barely a million dollars of shares traded.

I think there is something to that. Especially when, if management is asked a question about probuphine on a conference call (sales estimates, timing of chronic pain supplemental NDA), they have to admit that they don't know.

Which is why many of us are so frustrated of the lack of progress over matters where management is calling the shots: development of the Pro Neura platform and a ROW partnership.

A convincing "story" for management to tell is they have a great Pro Neura platform (T3, Parkinsons and other indications) that can be funded without further dilution by using probuphine royalties and milestones. But they have to show execution on that platform.

Thanks for posting that. I will need to look at this chart a couple of times before I can sleep tonight

Agreed...tonight no news isn't great news, but it's definitely not bad news. Now if they open tomorrow without a pre-market press release, things get a little dicier.

Ugh, I was holding TTNP when that CRL came through, not a fun night. Makes me a little jumpy right now. But that CRL came after a rather scathing FDA review document at an Ad Com, and blistering commentary from the FDA staff.

In this situation, while I fully realize a CRL or delay is possible, no one has really explained what the justification would be based on clinical trials. Possibly a labeling issue I guess, which can be easily corrected and doesn't require further testing. But from my understanding of the trial results, there is nothing to support any labeling issues.

Is it possible the FDA wants to be out front on this one? In other words, because it relates to opioids, they want their press release issued first, and are finalizing that before notifying ELTP?

Who knows. But in all candor, the waiting stinks.

True. But 35 cents per share is the most I will lose. What will it open at if approval is announced pre-market? More dangerous to be short right now.

They know whether labeling has been agreed to and finalized, so they definitely know whether approval could happen today or not.

If labeling hadn't been agreed to and finalized, then there is no chance of approval, in which case I think they would have PR'ed it.

Indeed.

Epic is not in the pain space in the US, and would have to invest substantially in order to meet the minimum license fees.

So let's say a pill is sold for $5.00, and costs $.50 to make.

ELTP receives cost ($0.50) plus 10% ($0.05) for making the pill ($0.55), and received 50% of the sales price ($2.50) in royalty. That leaves $1.95 for EPIC, out of which they have to fund sales people, marketing, and other selling expenses.

Early on, the costs of the additional infrastructure necessary to meet the minimum sales amount are likely to eat up any potential profit. But they have to spend that money quickly in order to meet the minimum royalty payments.

So, they may be incentivized to transfer the license rights to a third party for a price (funds advanced to EPIC plus profit). That third party would likely be whomever acquires ELTP.

The arrangement with LPC is like a line of credit that ELTP draws upon when it needs money and immediately pays for through the issuance of shares. LPC cannot sell until ELTP makes a draw and issues shares in return for cash.

That's not true, which you are already aware of. Look, there is more than enough room for doubt, you don't have to fabricate things.

It is abundantly clear that the S-1 relates to 63,000,000 shares which may be issued to Lincoln Park. The issuance has not occurred, and will only occur if ELTP exercises its right to cause Lincoln Park to purchase. Having a shelf resale prospectus on file is standard in such an arrangement, to allow LP to unload the shares IF ELTP chooses to sell them.

Part of the selling has been Braeburn, and part of it has been warrant holders converting.

From the conference call, NH truthfully agreed that it was possible to abuse SequestOx orally. I thought that was interesting.

Pfizer received abuse deterrent labeling for Embeda reading "Embeda has properties that are expected to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted."

However, with ALO-02, the Advisory Committtee "recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. They voted against inclusion of abuse-deterrent labeling for the oral route (6 to 9)." The fact that the Committee voted against oral labeling tells me Pfizer asked for it (otherwise, why ask the AC to vote on it?)

So it appears the FDA is taking a hard line on oral labeling. But perhaps Pfizer wants to fight for the label they got for Embeda plus intravenous.

If ELTP can live with a label providing for just intranasal and intravenous abuse deterrence, then there shouldn't be any labeling issues requiring a delay. And thus, approval.

Who knows...2.5 million short is just crazy. And we are at 93 cents a share pre-split, so there really isn't that much farther to fall...especially given we were around .70 cents a share this time last year (if memory serves), had not submitted the NDA, did not have an approved drug and had not received a $15 million milestone.

Well, this is interesting to say the least! Kind of reminds me of the Dirty Harry movie "Go ahead, make my day."

With respect 4.7 million shares traded out of 730 million outstanding is not huge volume (about six-tenths of one percent). Basically $1.67 million of a $247.0 million market cap. So drawing any conclusion one way or the other from the volume doesn't seem warranted to me.

I thought there would be a delay for sure last week, but now, I say that a delay would have been communicated to ELTP by the FDA and announced in a press release by this late date.

Sure I have reservations that the FDA could still pull some crap at the end, but such is life. The weight of the evidence is they will make a decision one way or another tomorrow, and I haven't seen anything leading me to believe a CRL is a possibility.

I could get burned. That's life. But the five or ten cents a shorter is going to make on his trade if there is a delay is nothing compared to the gains of longs on approval.

No expert, but in the last approval I witnessed the FDA posted on its website first (300pm day before the PDUFA) and the company followed shortly thereafter (TTNP).

Excellent points. Man, that is a lot of shares!

There was so much shorting pre-approval I can't help but wonder if someone (perhaps the market maker) got their shorts tied in a knot (no pun intended) and is purposefully trying to bring the price down so they may cover. It's not working, so their short position grows from week to week, because without continued shorting they would have to cover.

Conference call is in a month for 2Q results. Can't wait for "We are completely on track to be in the middle of the end of the process of beginning to contact opinion makers and regulatory experts about potentially beginning to consider initiating discussions necessary to begin to possibly...."

Sherlock knows the answer

"Eliminate all other factors, and the one which remains must be the truth."
Sherlock Holmes, The Sign of Four

After a lot of DD, the precedent for the latest release of a press release announcing the FDA had provided notice of a delay of review of a NDA that I could find occurred premarket the morning before a PDUFA date. So, if historical statistics mean anything, there is no precedent for a delay caused by the FDA's failure to complete review.

The precedent for the latest release of a press release announcing the FDA would delay 90 days because of a material amendment extension of the PDUFA date I could find was four days before the PDUFA date. So, the announcement of an 90 day mandatory extension because of a material amendment would also be unprecedented.

As others have opined, an AdComm will not be required as no novel issues are involved (see the FDA's recent cancelling of the Ad Comm for Pain Therapeutics' Remoxy for that reason).

So its basically CRL or approval now.

And as others have opined, there is no precedent for a priority review drug without an Ad Comm to receive a CRL.

"The world is full of obvious things which nobody by any chance ever observes.” Sherlock Holmes, The Hound of the Baskervilles

Wow, great post, thanks. I'm not as knowledgeable as many here, but I noticed in the license agreement filed today that ELTP will receive a 50% royalty on sales from Epic, plus get paid cost plus 10% to make the pills. So basically it's all profit to them, and the 70% of operations spending may be a little high...increasing the EPS significantly.