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  • Vical: 2012 Should Be A Huge Year [View article]
    I share the author's optimism on Vical, though probably to a lesser extent. I share GG's concerns on the errors of fact in the article.

    Vical announced last week (Feb. 8, 2012) that data from the Allovectin trial won't be out until the end of the year.

    And even assuming the data is good for Allovectin, it still won't be "followed shortly thereafter by FDA approval (45 days from receipt of letter per SPA)", as the author states. Vical will have to put together their NDA filing-- easily a 5-8 month process. Then the FDA has 6 months to review it (that's with the accelerated review process). So Q4 2013 looks right, if everything goes smoothly.

    Finally there's this confusion: "Initiation of phase 3 trail for Astellas (a herpes vaccine) in transplant patients". The phase 3 trial the author is referring to is for a cytomegalovirus vaccine, not a herpes vaccine. The vaccine is not called Astellas, but it is partnered with the pharmaceutical company Astellas.
    Feb 16, 2012. 05:22 PM | 2 Likes Like |Link to Comment
  • Vical's Herpes Vaccine Headed To The Clinic [View article]
    I agree that the HSV-2 vaccine looks promising. Unfortunately, they still have preclinical testing to do. From the CC transcript:

    "We are currently preparing to conduct the safety talks and by distribution studies to support an I&D application." (Translation: We are currently preparing to conduct the safety tox. and biodistribution studies to support an IND application.)

    They then go on to say that they want to start the PhaseI/II trial "as soon as possible." I would guess that probably puts it in Q3 of this year, with the results available maybe Q1-Q2 2013.

    For this year, Allovectin-7 in cancer is all the clinical news we're likely to get. I think that's likely to be good news, but my point is HSV-2 is going to be a long time coming.
    Feb 9, 2012. 10:58 AM | 1 Like Like |Link to Comment
  • Trius Therapeutics: Outstanding Potential, Discount Price [View article]
    Wow, it's holding up better than I would have expected considering that this sale (including over allotment) is a nearly 35% dilution. I suppose there must be a lot of buying interest, given it was trading around $7 in November-December, and its prospects are only improving with time.
    Jan 26, 2012. 11:24 AM | 1 Like Like |Link to Comment
  • Vertex Pharmaceuticals: Great Pipeline, Valuation And Future [View article]
    It's not had a lot of attention, but Vertex has already completed an all-oral Incivek + VX-222 + ribavirin trial. They should announce the results this quarter. If the results are positive, this all-oral combination would be in phase III fairly quickly, putting it maybe 6 months behind the competition. Not an ideal position, but better than what the stock price suggests.
    Jan 23, 2012. 01:03 PM | Likes Like |Link to Comment
  • Big Pharma, Take Note: Prolor Biotech's CTP Technology Yields Bio-Better Proteins [View article]
    Prolor's technology looks great for hGH-- taking it from once a day to once a week. Unfortunately, almost all of the big $ biological drugs out there are already dosed once a month. There are a few exceptions that are injected once every week or two weeks. But really, hGH is the only big opportunity for this technology among existing drugs.

    There may be future biologics that need stabilizing. If the unpatented methods (glycosylation, PEGylation) don't work, maybe big pharma would pay for Prolor's technology. But those are some significant "if"s and "maybe"s, and future biologics are going to be much riskier bets than bio-betters.
    Jan 20, 2012. 02:17 PM | Likes Like |Link to Comment
  • Nanosphere's Extraordinary Growth Potential in Medical Diagnostics [View article]
    Certainly the approvals are good news. They're part of what needs to happen for NSPH to be successful. Previously, they had 3 tests approved in the US and 4 in the EU, generating $140k per customer per year (PCPY). The full bloodstream infection test (this approval was just for staph. aureus) is expected to generate $90k PCPY once it's fully rolled out ($50k this year). So relative to existing tests, it looks like this one is a pretty big revenue driver.

    Basically, the thesis on this is still intact. The Plavix delay in the US hurt. And while they planned on having 8 tests approved by the end of 2012, now it's looking like they'll have 7, with the Enteric panel test pushed in to 2013. These new approvals mean they're executing roughly according to plan though. They'll still have ~$40 million cash now, which should last them until mid-2013 at least. With the delays, I'm afraid they'll have to raise some more money late this year or next year, which is unfortunate. Still, NSPH's success looks more likely than not, and if they do succeed, the returns are still likely to be in the 300+% range from current levels.
    Jan 5, 2012. 06:08 PM | 1 Like Like |Link to Comment
  • Nanosphere's Extraordinary Growth Potential in Medical Diagnostics [View article]
    I just got this question from user "uneesila":

    Could you please comment on why the troponin assay would be adopted if the current assays take only 15 to 30 min. and every other assay of nanospher take 2.5 hrs. Do you know how long the Nanosphere troponin assay takes to get a result?

    To the best of my knowledge, the troponin assay will also take ~2.5 hours. The point with this assay is not that it's faster, but that it's more sensitive. Troponin levels build up slowly after heart damage. With current assays, troponin levels must reach 0.04 ng/ml before they're detectable. That takes 8-24 hours after patient admission. Nanosphere's assay is good down to 0.002 ng/ml (20 times more sensitive), and most (86%) of patients have reached that level as soon as they show up in the emergency room. Two hours after admission, all patients have reached that level. So with nanosphere you can be 100% sure of the patient's status in ~4.5 hours (2 hours post-admission + 2.5 hour assay), compared to 24 hours for the standard assays.
    Oct 9, 2011. 01:07 PM | Likes Like |Link to Comment
  • Pfizer Guidance Suggests Tremendous Potential for Pain Therapeutics [View article]
    If I said there was a 100% chance before, then I would have been wrong. Since I said there was a 75% chance, I was either unlucky or wrong. I'm inclined towards unlucky, but that call is up to the reader to make.

    As listening to me? I'm not saying you should. I'm just suggesting you might want to listen to Pfizer's CEO.
    Oct 2, 2011. 01:19 PM | Likes Like |Link to Comment
  • Nanosphere's Extraordinary Growth Potential in Medical Diagnostics [View article]
    That link is no good. Here's the original.;p=irol-newsArticle&am...

    The results are good. I think the only questions are how soon does it get approved and how much value does this create for physicians. NSPH needs a test that is going to make physicians say, "We *need* this." Once that happens, we're off to the races. Until that happens, it's not going to be any fun being a NSPH shareholder.
    Sep 20, 2011. 12:35 PM | Likes Like |Link to Comment
  • Nanosphere's Extraordinary Growth Potential in Medical Diagnostics [View article]
    There is no question that competition from Cepheid and others might lead to the failure of NSPH. In the absence of competition they would be almost 100% likely to succeed, and this would be a no-brainer investment.

    The advantage of NSPH over Cepheid is the ability to do multiplex tests: NSPH's bloodstream infection and respiratory virus tests can detect any of a large number of pathogens, while a Cepheid cartridge would test for just one. Also, if I understand Cepheid correctly, their technology is nucleic acid based, while NSPH can look at nucleic acids and proteins (troponin, PSA).

    Will those advantages be maintained? And will they be enough to let NSPH survive and thrive alongside Cepheid? Only time will tell. The reason (I think) it makes sense as an investment is: it can only lose 100% on the downside, and there is the likelihood of several hundred percent on the upside. It all comes down to this: how likely is that success? If it's greater than 25%, NSPH is a solid investment here.
    Aug 31, 2011. 02:47 PM | Likes Like |Link to Comment
  • Nanosphere's Extraordinary Growth Potential in Medical Diagnostics [View article]
    They sold 12 in Q1. I think the delay in the (U.S.) Plavix assay is what hurt them on sales this quarter. That assay is already approved in Europe. Of the 8 sales this quarter, 7 were in Europe, 1 in the U.S. Management is now anticipating U.S. Plavix approval in mid-2012.

    I would add that those 8 new systems represent a 15% increase on the total systems they have in the field (50 last quarter, now 58).

    As for the earlier question of how much of the revenue is from system sales and how much is from cartridges, the answer is, "it's complicated". Some customers buy the systems, others get the system for "free", but pay more for cartridges. I'm not sure how it all breaks out.
    Aug 15, 2011. 03:32 PM | Likes Like |Link to Comment
  • Nanosphere's Extraordinary Growth Potential in Medical Diagnostics [View article]
    I am still holding. It's been painful, but I do think this will work out well over the next couple years. From the conference call: They're getting ready to start selling in Asia/Pacific by the end of the year, and they'll have four new filings with the FDA by the end of the year (Plavix metabolism refiling, bloodstream infections, C. Difficile, & Troponin). And they have the cash to get through mid-2013 at least.
    Aug 11, 2011. 02:00 PM | 1 Like Like |Link to Comment
  • Depomed: Light-Risk Small Pharma With Huge Potential [View article]
    Thanks for your valuable addition to this conversation. Do you have some insight suggesting that this stock does not have a great risk reward profile? There's nothing in today's press release or conference call that makes me less optimistic about this company/stock. It's just available at an even better price. I'm adding to my long until someone can show me some real evidence that the story has changed for the worse for DEPO.
    Aug 2, 2011. 06:39 PM | Likes Like |Link to Comment
  • Nanosphere's Extraordinary Growth Potential in Medical Diagnostics [View article]
    As of April 28, 2011, $30 million was about right. On May 13, 2011, they raised another $32.1 million through an equity offering at $2.20/share. So the current number is roughly $60 million.
    Jul 5, 2011. 02:07 PM | 1 Like Like |Link to Comment
  • Careful Analysis Reveals Good Probability of Large Gains for Vical [View article]
    The historical controls certainly can't be compared to the A-7 phase 3 patients. The phase 3 patients have indeed been selected to have a longer median survival.

    On the other hand, there was minimal selection for the A-7 phase 2 trial. The only exclusion criterion was that brain metastases weren't allowed. Patients with brain metastases do die more quickly, but they're not a big percent of patients. As such, excluding them shouldn't have a big effect on median survival.

    Therefore, the historical controls should be appropriate for comparison to the A-7 phase 2 results.
    Jun 28, 2011. 03:02 PM | Likes Like |Link to Comment