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The June 25 date is from 2013 - not 2014. Someone incorrectly posted this on Sheff's board too and was met with a "thanks for the info!" from him... so much for fact checking.
Also, anyone referring to a 6-month timeframe from the date of submission is incorrect in that sense as well. Read the FDA website, the FDA has 45 days from the date of submission to accept the PMA for filing at which point the 180-day timeframe begins. It does not begin at submission, only when it is filed.
All that being said - very bullish, should get an answer any day within the next few weeks.
Trading will resume at 5:55 PM
http://bit.ly/1l63GNH
FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm401085.htm
Marqibo net sales Q4 2013 were reported as $1.3 million yesterday by Spectrum. Still, no idea how that stacks up with any milestone since we never received the information.
Napodano's newest article outlines his bold prediction on TTNP.
http://www.seekingalpha.com/article/1916471-4-bold-biotech-calls-for-2014
Prediction # 1: Braeburn Will Double-Down on Titan Pharmaceuticals
Titan Pharmaceuticals (OTCQB:TTNP) has been on a wild ride the past year. The stock traded as high as $2.50 per share early in 2013 ahead of the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) meeting that took place in March 2013 to discuss the company's new drug application (NDA) for Probuphine. Probuphine is Titan's implantable buprenorphine for the treatment of opioid addiction. The PDAC members voted to recommend approval of the product in March 2013. Just a few months earlier, in December 2012, Titan licensed the product to privately-held Braeburn Pharmaceuticals. Things were going well for Titan, including the FDA granting the product priority review in January 2013. As such, it was quite a surprise to Titan investors when the FDA issued a complete response letter (CRL) in April 2013.
We discuss the issues that comprise the CRL in this more detailed Seeking Alpha Pro article published in August 2013. The general gist of the letter was that the FDA, perplexingly, put more weight on the pharmacokinetic data than the actual human clinical data. Quite simply, the agency seems to want to see buprenorphine blood plasma levels similar between Probuphine and Suboxone, the current market leading product produced by Reckitt Benckiser. Suboxone generates roughly $1.5 billion in U.S. sales. The FDA gave pause to the Probuphine application because blood plasma levels in patients with Probuphine were far less than those taking Suboxone tablets, and that lead the agency to believe the product was not as effective as the current gold standard. This was despite the fact that Titan conducted a Phase 3 trial, PRO-806, directly comparing the two drugs that demonstrated statistically significant non-inferiority between the two products (36% vs. 35% negative urine samples during weeks 1-24 for Probuphine and Suboxone, respectively). This data has been both published and presented for peer-review.
Titan held a Type-C meeting with the U.S. FDA on November 19, 2013 in an effort to better understand the issues of the CRL more fully, and to review and discuss data with the agency. Earlier in the week, Titan announced that it had essentially found a path forward with the agency that revolved around experienced sublingual buprenorphine patients that are "stable" on 8 mg of drug daily. This is in contrast to the original application which called for use of Probuphine in opioid addicts starting therapy on Suboxone. We believe this effectively relegates Probuphine to second-line use, or as a maintenance therapy, at least with respect to the label / indication for use. We think once approved, addiction medicine doc will probably still use Probuphine at a similar rate to how we predicted prior to the complete response letter, or in around 5-10% of all their patients. In essence, we see the narrower label as having only a minor impact on peak sales.
Titan and Braeburn noted that secondary issues listed in the CRL, include finalizing the Risk Evaluation and Mitigation Strategy (REMS) and potentially doing a human factors study on the insertion and remove of the implant, are also being worked through. This does not concern us.
With respect to finding a path forward, it is now clear that Titan must conduct another Phase 3 trial with Probuphine, only now in patients stabilized on 8 mg of sublingual buprenorphine vs. the PRO-806 trial which enrolled patients stable on 12-16 mg. We find a number of things here interesting. Firstly, the agency told Titan that the trail "need not be large" but "adequate and well-controlled". We remind investors that the PRO-806 study enrolled a total of 287 patients and compared Probuphine to sublingual buprenorphine and placebo in a 2-2-1 randomization. We think Titan can get by with probably 200 patients in this next (yet finalized) Phase 3. Titan plans to submit a protocol assessment to the FDA in the next few weeks. PRO-806 initiated in March 2010, completed enrollment in September 2010, and offered up top-line results in July 2011. Data from PRO-806 was delayed around two months because the FDA requested a new statistical analysis plan from Titan in June 2011. We assume the new trial can begin in March 2014, enroll by the end of the summer 2014, and offer up data in the second quarter of 2015. PRO-806 cost Titan around 14 million all-in. We suspect that a new shorter, quicker Phase 3 can be down for around $9-10 million all-in. This will be funded by Braeburn. Assuming secondary issues are worked through concurrently, we suspect a re-filing of the application by the middle of 2015. With a six month review, the new PDUFA for Probuphine is looking late 2015.
But beside the quicker and shorter Phase 3 trial, we find it most interesting that Titan will compare Probuphine head-to-head with a lower-dose sublingual buprenorphine. We remind investors that data from PRO-806 shows Probuphine is statistically similar to the 12-16 mg Suboxone dose - note the aforementioned 36% vs. 35% negative urine samples during weeks 1-24 for Probuphine and Suboxone, respectively, discussed above. The FDA is now making Titan and Braeburn do another Phase 3 to make sure it's comparable to a lower-dose. That's odd, but nevertheless gives us great confidence in the outcome of this new Phase 3. So from a trial risk standpoint, we think Titan investors have little to worry about.
The biggest issue for Titan investors today is the company's cash position. We remind investors that Braeburn just recently renewed its commitment to Titan and the product in November 2013. Braeburn now owns 9.65 million shares at an average price of $0.96 per share. That's 10.9% ownership. Titan has cash to get to early 2015. They are going to need added cash to support operations into 2016, we estimate to the tune of around $8-10 million. We think there is almost no chance that Braeburn lets Titan run out of cash, or at the very least, raise capital in the open market. Instead, we think Braeburn will double-down on its investment in Titan, seeking to bring its ownership level closer to 20% by the end of the year. For Titan investors, this is the most shareholder friendly path forward, and could be a prelude to an outright acquisition of Titan by Braeburn following Probuphine's final approval in about two years.
Not a clue. Can't seem to find the info anywhere, but numbers like that definitely won't get it done. It'll be easier to assess if we should ever expect a penny based on the 4Q numbers when Spectrum releases them in Feb. '14
Net sales for Marqibo Q3 was 100K
You'll have to explain to me how this is customary. They just increased their share count by 50%. I understand needing money for operations, but 60 million? It wouldn't seem to be logical that it will hit the same high that it hit earlier this year with 150 million more shares available. I'm thinking .65 and MAYBE .80 upon approval.
All that said I do agree that now is a time to enter and will be rooting for approval
Two clinical trial initiations in December could also give it a little boost short term
Maybe you haven't paid attention, but that will not be happening as you describe it. Tomorrow we will get the results of a vote on whether or not to approve a name change for the company to Huron Therapeutics and also whether or not the company will be allowed to conduct a reverse split.
The assumption would be that the reverse split will take place and they have stated it will be somewhere between 10-1 and 20-1. After the split the price will likely be in the $4-$5 range and the company will uplist to NASDAQ.
Did we get it?
Can anybody outline any information the CEO gave in regards to a possible NDA resubmission in the fall? Or was it just simply that? Or nothing at all...
Sarcasm is tough to read I suppose. Obviously you shouldn't come on here for advice, which is why your post is so ironic.
So what you're really saying is that everyone SHOULD be here for advice?!
That's a myth. There's no 30-day requirement for uplisting
I agre with you, it's completely undervalued. That will correct itself in the coming months
They don't see a dime of that, it deserves several asterisks. The real figure is the real story, and it is still very positive.
I'm invested in FNMA and believe in the company's future success, however, I feel like you're confusing yourself and mixing up your quarterly and annual numbers.
You're using an annual profit and comparing it to these companies quarterly profit. Apple, for example was more profitable Q1. FNMA posted 8.1 billion for the first quarter.
Well I can tell you that they are free to announce a CRL whenever they please, there will not be an FDA press release in that case. No news is likely to be bad news the longer it goes. But let's hope that's not the case!
NRIFF hopes the requested study will be completed and the NDA for PENNSAID 2% will be resubmitted 3Q 2013 with an FDA decision on approval in or before 1Q 2014.
http://www.nuvoresearch.com/investors/documents/2013-03-18_Nuvo_Pennsaid2_QandA.pdf
Conference call: CEO says the manufacturing issue already being addressed. Won't give specifics on human factor study timeline at this time.
While not completely insignificant issues, this seems like nitpicking more than anything.
Like during the presidential election?
Everyone's favorite bio dream crusher Feuerstein just suggested the final vote on this should be 15-0 for approval on the live blog.
How the hell do you block someone's posts on here? I ignored Dan and yet they still show up. I like relevant info and he floods the board with garbage all day
Gonna have 1 billion + in volume today
Pump email special today. Expect huge volume
I don't have a source for you, but in general it would vary company to company. Some companies have large production facilities ready to pump out millions of units while others are not as capable short-term for various reasons. Each company obviously has some capacity to produce the product from day one of the clinical trials, and the FDA reviews their manufacturing processes as a whole as part of the decision to approve or reject. The speed at which the drug would hit the shelves after approval depends on production capacity. Some companies may also try to sell their product to a big pharma after approval rather than put it on the shelves themselves and you may wait months before hearing anything about it.
Nice chance to scoop up some even cheaper shares over the next few months before resubmission.
News is imminent at this point. No news AH is most likely bad news!
NRIFF .07 - FDA decision due today to decide if they will approve pain product Pennsaid 2%. Prospects look good for approval and for long term success of the company in 2H 2013. Under the radar FDA play here - not very common.
I saw that one as well. I'm basing my prediction on the fact that they called it a bottom play. ACTC seems to be more bottomed out, although CBAI definitely does fit into the price range of their typical selections.
Companies pay these email distribution marketers to pump their stock. ACTC obviously paid for their service for next week. The email came out today but they didn't specifically say what company it is, but with a little research on their details, it points to this stock. They withhold the name until the markets are closed so that they can buy up a boatload of shares before everyone pumps this up to 20 cents on Monday at which point they'll sell. They release the stock symbol over the weekend so on Monday morning there is an explosion of volume.
Volume 300K+ and all buys
2 trading days until PDUFA!
Change of heart?
I'm surprised this hadn't gotten any love on $heff's board - they're usually all over the FDA catalysts.. even OTCs when it comes to something like a PDUFA.
Picked some up here EOD. Interest has to come eventually, right?
Is anyone playing NRIFF? I feel like there has been an unprecedented lack of interest considering the PDUFA is one week away. No volume!
New Seeking Alpha article
Positive and informative.
A.P. Pharma: PDUFA Date On APF530 Looms And I Am A Buyer
January 25, 2013
I initiated coverage of A.P. Pharma (APPA.OB) in April of 2012 with a Buy. I am anticipating approval of its lead drug, APF530 at the March 27, 2013 PDUFA date. I believe that the company has successfully answered the CMC issues that resulted in a Complete Response Letter to its earlier NDA application. I project that in stark contrast to almost all recent biotechnology product launches that APF530 will have a rapid takeoff following a potential 2013 launch. Please refer to reports on my website for a more in-depth analysis of the company.
The stock has been strong recently based on a trading game that goes on in many cases prior to a PDUFA date. Some short term traders buy the stock in the days leading up to the PDUFA date and then sell it just before the PDUFA date. This has nothing to do with the timing of this report. I am not good at short term trading ideas like this and my investment time frame is much longer, often years. Warren Buffett in a way that only he can do summarized my disdain for short term trading when he said that "Long ago, Sir Isaac Newton gave us three laws of motion, which were the work of genius. But Sir Isaac's talents didn't extend to investing: He lost a bundle in the South Sea Bubble, explaining later, 'I can calculate the movement of the stars, but not the madness of men.' If he had not been traumatized by this loss, Sir Isaac might well have gone on to discover the Fourth Law of Motion: For investors as a whole, returns decrease as motion increases."
I am estimating peak sales of $200 million for APF530 in 2014 and EPS of $0.22. My price target for late 2013 is arrived at by applying a P/E ratio of 20 to projected 2014 EPS of $0.22 and results in a price target of $4.40. Please note that in my models, I have assumed that the product will be launched in mid-2013. The company is only giving guidance that the launch will be in 2H, 2013. If the launch were to occur much later in the year, it might push peak sales into 2015; a somewhat later launch would not appreciably alter my thinking on the stock.
APF530, is being developed for the prevention of chemotherapy induced nausea and vomiting or CINV. It is an injectable drug that uses the company's Biochronomerâ„¢ polymer-based, sustained-release delivery technology to deliver the widely used generic drug granisetron. It increases the time of effectiveness for granisetron from one to five days, which provides important therapeutic advantages.
There is a compelling clinical reason to use APF530 when the only other approved drug for treating delayed onset vomiting, Aloxi, fails to completely halt vomiting, which is about 30% to 60% of the time. A 1,341 patient Phase III trial showed that APF530 is as effective as Aloxi and thus offers the physician an alternative when Aloxi fails to establish complete control. Importantly, there is also a compelling economic reason to use APF530, which I discuss in detail shortly.
Very importantly and in contrast to most recent new biotech product launches, I am projecting a rapid takeoff. This projections stems from a pricing peculiarity under Medicare part B that creates an economic incentive in the early stages of a launch for many providers/physicians to use a new drug.
It is imperative that A.P. Pharma stages an aggressive launch for APF530 to maximize its market position during the economic window of opportunity in the early launch period. It raised $54 million in 3Q, 2012 which gives it the option of building its own small sales force to market the product. The CINV market is relatively small and can be covered with about 40 reps. I estimate that putting a sales force in place and then launching APF530 would cost about $15 to $20 million and this is within APPA's reach. This strong cash position also puts the company in a strong negotiating position if it opts to license APF530 or sell the company outright after product approval.
Medicare Part B Reimbursement is Very Favorable to APF530
Clinical benefits alone could allow APF530 to gain a meaningful share of the CINV market. However, there are also strong economic incentives for doctors to prescribe APF530. The reimbursement of injectable 5-HT3 drugs, the class to which APF530 belongs, is covered under Medicare part B regulations which set the pricing for Medicare and the Medicare price is then closely followed by private insurers. Aspects of the reimbursement regulations create economic incentives which favor newly introduced drugs over older ones.
Let me show how this Medicare pricing works in the case of Aloxi. The wholesale acquisition price or WAC for Aloxi is about $380, but it is sharply discounted so that I estimate that its actual average selling price or ASP that providors actually pay is about $175. The manufacturer is required by Medicare regulations to gather and submit actual billing information from accounts which is used to calculate the ASP. Physicians are then reimbursed for the ASP plus a 6% markup. In the case of Aloxi, the drug is purchased by providors for about $175 and reimbursed at $186 due to the 6% markup; this results in about an $11 profit from this factor. In addition, physicians also bill for an administration fee that is roughly $20 per injection. Hence the physician receives $11 plus $20 or roughly $31 per injection of Aloxi.
Medicare part B regulations create a unique situation that is very much to the advantage of new drugs. The pricing regulations are based on historical ASP, but new drugs have no pricing history. Instead, new drugs are reimbursed at markup over WAC prices for roughly two full quarters following introduction. For example, if a drug were introduced on July 1, 2013, it would probably be reimbursed at a markup of 6% over WAC until December 31, 2013. Reimbursement would then shift to a markup over ASP.
Let me illustrate how APF530 could benefit from this. Let us assume that it is introduced at a WAC of $380, the same as Aloxi. For 6+ months, physicians would be reimbursed at a 6% markup over WAC or $403. APPA during this time could elect to discount APF530 and sell it to doctors at perhaps $260 so that the difference between $380 and $260 or $120 would be profit for the physician. The total profit for physicians would be $120 plus the markup of $11 and the administration fee of $20 for a total profit of $151 on APF530; this compares to $31 for Aloxi per my previous example. Past experience suggests that a $30 difference in price can induce physician prescribing behavior and the difference in this case would $151. Please note that the $380 price on APF530 and the possible approach to discounting is pure speculation on my part as the company has made no comment on pricing plans.
This initial discount incentive lasts for six and possibly as long as nine months past the launch, the period during which Medicare determines the actual selling price of ASP. What happens next? Over this time, APPA gives Medicare the necessary data to calculate an ASP. Physicians then begin to bill at a markup over the newly established ASP; Medicare is continually recalculating ASP. However, this doesn't immediately eliminate the incentive enjoyed by APF530. For example, if we assume that during the first six month introduction period for APF530 that the physician is actually paying $260 per injection, this then becomes the new ASP on which reimbursement is calculated. Remember that the ASP for Aloxi is $175 so that APF530 can still provide a meaningful discount. If the ASP is $260 and APF530 is discounted to $220 per injection, the physician could still realize a profit of $76 per injection versus $31 for Aloxi. Hence, this economic incentive can probably be maintained for some period past the first six plus months following introduction.
The market for Aloxi usage according to data presented by A.P. Pharma in its latest presentation indicates that about 2.8 million units of Aloxi are sold annually. Of this, about 2.2 million goes to cancer clinics and 0.5 million to hospitals. The clinics are generally profit making institutions that will respond to an economic incentive. This powerful economic incentive along with the substantial unmet medical need is the basis for my projecting a rapid uptake following the launch of APF530.