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JDS Uniphase Corporation Message Board

rspiland3 21 posts  |  Last Activity: Aug 28, 2015 12:24 PM Member since: Feb 23, 2012
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  • Reply to

    Some notes about PH III NX-1207 DATA

    by iome70 Aug 28, 2015 8:35 AM
    rspiland3 rspiland3 Aug 28, 2015 12:24 PM Flag

    United States and Rest of World. GSK is GlaxoSmithKline. In general, a development stage biotech with a successful drug candidate can sign one global deal, or they can license their drug to several partners for different regions. Further, they can license it at any stage of the approval process.

  • Reply to

    Some notes about PH III NX-1207 DATA

    by iome70 Aug 28, 2015 8:35 AM
    rspiland3 rspiland3 Aug 28, 2015 10:52 AM Flag

    I agree with fenix1357...I haven't spoken with Recordati, But Dr. Averback sounded pretty definitive when I asked if there was any consideration of resurrecting that trial. I too expect a licensing deal for U.S. and ROW, and I would really like to see it before filing the NDA.

    I like GSK as a partner...global company with a presence in urology. Avodart goes off patent in November...big loss for GSK, and a NYMX deal would more than replace those lost sales.

  • rspiland3 rspiland3 Aug 27, 2015 11:32 PM Flag

    Obviously already had a position previously (when he was appointed to the board?) Now that he's added and is over 5% of shares o/s, he has to file the 13D. Robinson is a dynamo and lifetime over-achiever. Made a fortune detailing imported cars in the Port of Baltimore. Then bought Subaru Mid-America distributorship, turned it around, and sold it. Then started and still runs a fabulously successful film production company. I like his involvement with the company!

  • Reply to

    Institutions own

    by ricjohn2 Aug 26, 2015 11:36 AM
    rspiland3 rspiland3 Aug 27, 2015 10:31 AM Flag

    Can only speculate...BPH symptoms aren't always present or problematic, and can depend on diet, lifestyle or lifestyle. For instance holding your pee can cause them to flare up; peeing as soon as you feel the need can help mitigate symptoms...for a while. But the condition is progressive, and over time lifestyle changes are less effective. In all likelihood, participants would have also made lifestyle modifications which (1) would not disqualify them from the trial, and (2) would be less effective in a longer trial.

    Also a point made by Dr. Averback on the conf. call...for unknown reasons, placebo response rates seem to be higher for procedures than they are for a pill. An example he used was the initial trial for Botox.

  • Reply to

    Institutions own

    by ricjohn2 Aug 26, 2015 11:36 AM
    rspiland3 rspiland3 Aug 27, 2015 10:15 AM Flag

    Sure it's credible! Only about 25% of men diagnosed with BPH even get treatment. There are around 14 mil guys diagnosed with the condition. Only around 3.3 mil are getting medication, and each year about 200k of the most disruptive cases are treated surgically. So 75% live with it and hope a better treatment comes along.

  • Reply to

    Institutions own

    by ricjohn2 Aug 26, 2015 11:36 AM
    rspiland3 rspiland3 Aug 27, 2015 1:30 AM Flag

    Results from two double blind placebo controlled phase 3 trials were combined and failed at one year due to high placebo response. The FDA usually approves the original trial design, so combining two trials shouldn't be an issue. Same two trials were extended and succeeded at 42 months. Extension trials are common and have been accepted by the FDA. In fact the FDA sometimes requires them, even if a drug is granted conditional approval. I am not aware of any company comments to suggest patients with high scores were removed from the placebo group. I doubt the trials have been unblinded, so the company probably doesn't even know who may have been removed. Don't forget these trials took place at 70 facilities and were administered by a CRO.

    The FDA likes long-term data, and the safety profile is particularly important. These trials fit that bill. And no one really thinks an injection of mild saline solution is going to cure BPH. The company intends to file an NDA, and I think that will happen this year. Further, most existing medications are off patent; some big pharma company is going to want this drug. I like GlaxoSmithKline as a license partner, since Avodart goes off patent in November. And I would really like to see a license deal before they file the NDA.

    I think it's a pretty good risk/reward profile.

  • Reply to

    Institutions own

    by ricjohn2 Aug 26, 2015 11:36 AM
    rspiland3 rspiland3 Aug 26, 2015 6:35 PM Flag

    That's another point...it's too small for all but really specialized micro-cap managers. I would like to see more institutional interest, because it tends to boost valuations and stabilizes price volatility. But price (and institutions) will follow definitely respond to fundamentals.

  • Reply to

    Institutions own

    by ricjohn2 Aug 26, 2015 11:36 AM
    rspiland3 rspiland3 Aug 26, 2015 2:24 PM Flag

    Lack of institutional sponsorship has definitely been an issue for this stock, and I see two reasons for it. First, they never provided details on the chemical composition or MOA of the drug, other than to say it induces apoptosis. There could be good reasons for the secrecy, but analysts with a scientific background can't handicap the likelihood the drug will work as expected.

    Second, the CEO does not like wall street...is convinced all they want is fees, and always extract their "pound of flesh" from shareholders. And indeed he prides himself on diluting shareholders less than any other biotech. But as a result, they have virtually no sponsorship on the sell side or the buy side.

    On the first point, the successful phase 3 extension trial indicates the drug works, and the NDA will provide more detailed info on composition and MOA. And on the second point, I think new CFO Erik Danielsen will likely be more effective at interacting with institutional investors.

    I've invested in a lot of small biotechs, and I own this one. As I see it, filing an NDA and signing a license deal are the most important near-term events. If either or both happen this fall as expected, the stock should be a rocket. The market is huge and not well-served, and most existing medications are off patent. Drug companies and urologists both want to see this drug come to market. IMHO this could easily be a $2 bil drug a few years after approval.

    Sentiment: Buy

  • Reply to

    Analysis

    by petershkim Aug 5, 2015 12:07 PM
    rspiland3 rspiland3 Aug 5, 2015 11:48 PM Flag

    NDAs are usually filed within 3-5 months of phase 3 trial results, and I think the PDUFA date is typically 10 months from the date the NDA is filed. I'm bullish, but don't expect approval until late 2Q or early 3Q of 2016. Another catalyst will be a license agreement with a major pharmaceutical company, which I would also expect by the end of this year. That alone should push the stock to double digits imho.

    Sentiment: Strong Buy

  • rspiland3 rspiland3 Aug 3, 2015 9:18 AM Flag

    Normally you would expect NDA submission 3-5 months after P3 trial results. Good summary of recent events, but don't be disappointed if NDA takes longer than 14 days.

    Sentiment: Strong Buy

  • rspiland3 rspiland3 Aug 2, 2015 2:36 PM Flag

    Because filing the application means the FDA accepted the application without requesting additional information.

    Sentiment: Strong Buy

  • Reply to

    What value does robinson bring to NYMX?

    by deliberation1983 Jul 30, 2015 4:25 PM
    rspiland3 rspiland3 Jul 30, 2015 5:43 PM Flag

    Very successful self-made businessman with interests in automotive imports, movies, and other interests...real rags-to-riches story. He is based in Baltimore, as is investigative urologist Dr. Ron Tutrone, who has prominently endorsed NX-1207. I have no knowledge of this, but I would speculate Tutrone may have introduced Robinson to Nymox, and Robinson may have made a strategic investment in the company. He could probably buy this company for cash at the current price if he wanted to, so I have no problem with him on the board.

    Sentiment: Strong Buy

  • rspiland3 rspiland3 Jul 27, 2015 4:38 PM Flag

    Market size in $$ is deceptive, because drugs which have gone off patent (Flomax, Proscar and others) prices have declined so much. I've read 3.5 million patients get treated annually in the U.S. alone. If they get 20% share and charge $3,000 per dose, then $2.1 bil drug. Important to recognize drug companies need this drug to replace lost revenue streams. Also remember this drug is injected directly into the prostate; it's a procedure for which urologists will get paid. They don't get paid for writing a prescription, so both drug companies and docs really want to see this drug approved.

    Sentiment: Strong Buy

  • rspiland3 by rspiland3 Jul 27, 2015 12:41 PM Flag

    I'm not trading this stock...long term, and here's why. There are around 3.5 million men treated for BPH annually in the U.S. alone. Current treatments have limited efficacy; side effects include sexual dysfunction, male breast enlargement, etc. Also many current treatments have lost patent protection. GSK's Avodart loses patent protection in November. NX-1207 has shown better efficacy than current treatments and a much better side effect profile. Today's announcement that it succeeded relative to placebo means the drug should be approvable without further trials. Importantly, Urologists will be paid for administering this shot; they don't make anything writing a script for a daily pill.

    So figure 20% market share of 3.5 million patents at $3,000 per dose makes this a $2.1 billion drug. Royalties on late-stage drugs usually run 13%-19%...15% would be $315 million in annual license revs for NYMX. Assume 40 mil shares and a 40% tax rate, that's between $4.50 and $5.00 per share in license revs. And that doesn't include anything for the prostate cancer indication. Stock should be worth at least $40-$50 in a few years.

    Sentiment: Strong Buy

  • Reply to

    erning release - 3 days left

    by sm20505 Jul 26, 2015 8:19 AM
    rspiland3 rspiland3 Jul 26, 2015 11:44 AM Flag

    Estimates are worthless for ESI...look at past 3 quarters: 1Q estimate was 7 cents; reported 44 cents. 4Q14 estimate was .36; reported .63, and 3Q14 estimate was .27; reported .44. These aren't slightly better, but are massive beats!

    In response, Merrill and Wells have dropped coverage. Stifel's analyst left, and they dropped coverage. It's no longer an institutional stock, but appears to be back on track for strong profitability. That's usually a good time for a patient investor to load up. At some point, enrollments will begin to stabilize...should be very good for the stock.

    Sentiment: Strong Buy

  • Reply to

    BoA: 63% mobile customers now use MCD

    by nadullah62 Jun 29, 2015 6:56 PM
    rspiland3 rspiland3 Jun 30, 2015 11:38 PM Flag

    I'm with the bulls here. MITK was such a drag I almost stopped watching...always a great story, borderline cheap, but a disappointing performer. But I never sold, and added on dips, so now it's actually a pretty big position. MCD is still growing, and Mobile Account Opening and Balance Transfer have good potential. But I'm really excited about Identity Verification, and not just for banks. Migration to the cloud and the "Internet of Things" changes everything. And although identity verification is pretty secure in transactions for products, it is nowhere for cloud-based transactions for services. It may be a long shot, but if technology is as robust as MCD, then this is a huge market. And MITK could become a very hot stock.

    Sentiment: Strong Buy

  • Reply to

    Comprehensive fact base for ESI

    by boardman_ohio_trailerpark Jun 5, 2015 3:34 PM
    rspiland3 rspiland3 Jun 11, 2015 1:49 PM Flag

    Nice work! I concur with all of the above, which is why I am long size. Risk remains a corrupt and hostile legal/political environment. Regulatory cycle seems to be receding; I think COCO was the high-water mark for this regulatory cycle. Management actually has many levers to boost shareholder value. For instance, have you considered the possibility they spin off real estate into a REIT? Resolution of suits, stabilization and a resumption of growth alone should easily support a 12-15X multiple. But there could be more.

    Sentiment: Strong Buy

  • rspiland3 rspiland3 Jun 10, 2015 7:47 PM Flag

    I don't think ESI deserves the treatment they are getting, and I think their results compare favorably with those of public and private not-for-profit institutions. The stock is cheap, and I'm long. But the suits are a major risk, because the U.S. system of justice no longer offers protection under the law. This is a serious transformation in just the past couple of decades, and it deeply concerns me. Obviously the shorts are cool with that.

  • rspiland3 rspiland3 Jun 6, 2015 2:00 PM Flag

    I only posted infrequently, but am still in NYMX. In fact I was in small at $5, but bought a boatload below $1. Story is still alive, but risky. If NX-1207 is approvable, it could easily be a $2 bil drug in a few years. At a 15% royalty and a 40% tax rate, that's around $4.50 per share in after-tax license revs...$50-60 stock or more. But if the current trials for BPH fail, the stock is probably worthless, because they there isn't enough cash for new trials. I like Dr. Averback, and I know urologists have high hopes for this drug. And I have confidence that they are doing everything possible to bring this drug to market. So I am willing to take the risk.

    Sentiment: Strong Buy

  • Reply to

    Monday close 1.3 link here delisting

    by dia1na0 Jun 6, 2015 9:05 AM
    rspiland3 rspiland3 Jun 6, 2015 11:23 AM Flag

    Read more closely; ESI is NOT being delisted. They got a reprimand for not notifying the exchange prior to the press release. Sounds like a glitch in issuing the release, since it came out half an hour after the 10-K was filed. This is a non-event. People should stop fretting about this stock. It's stupid-cheap, and operating metrics appear to be stabilizing. Over time, ESI should be a great stock from here.

    Sentiment: Strong Buy

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