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    Pit Master schwi105's Avatar
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    Default NRI.TO NRIFF.PK Nuvo Research

    Nuvo Research Inc. - Home

    Ok. This thread was on that other site we are so kindly putting behind us; anyways, I have not seen anyone post about it here. Nuvo Research (NRI.TO, NRIFF.PK) has an upcoming FDA approval/rejection date of August 5, 2009. The drug of interest is Pennsaid.

    Company Information

    Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario with manufacturing facilities located in Varennes, Quebec and Wanzleben, Germany, and a research and development facility in San Diego, California.

    Nuvo is focused on developing targeted therapeutic products designed to produce minimal side effects. The Company develops drugs based on two technology platforms: transdermal drug delivery and immune system regulation.

    Nuvo markets two products Pennsaid®, a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis and Oxoferin™, a topical wound healing agent.
    Nuvo's primary focus is obtaining approval to market, and ultimately commercialize Pennsaid® in the U.S. market. Nuvo intends to leverage its transdermal drug delivery capabilities to create a portfolio of transdermal products targeting a variety of indications.

    Pennsaid Information

    Pennsaid®

    Pennsaid®Pennsaid®, the Corporation's lead product, is used to treat the pain and stiffness associated with knee osteoarthritis (OA). The drug combines a transdermal carrier (containing dimethyl sulfoxide, popularly known as DMSO) with diclofenac sodium, a leading NSAID, and delivers the active drug through the skin directly to the pain site. While, conventional oral NSAIDs have some serious systemic side effects such as gastrointestinal bleeding and cardiovascular problems, Nuvo's clinical trials suggest that some of these systemic side effects occur less frequently with topically applied Pennsaid®.

    The American College of Rheumatology (ACR) estimates that over 70 million Americans are affected by arthritis and musculoskeletal disorders and may have a substantial impact on an individuals quality of life and use of health-care resources. According to The Arthritis Society, arthritis and disorders of the musculoskeletal system are a leading cause of work-related disability.

    The ACR offers the following description:
    "OA is the most common form of arthritis in the United States. Patients with OA have pain (that typically worsens with weight bearing and activity and improves with rest), as well as morning stiffness and gelling of the involved joint after periods of inactivity. On physical examination, they often have tenderness on palpation, bony enlargement, crepitus of motion, and/or limitation of joint motion. Unlike the case with rheumatoid arthritis (RA) and other systemic inflammatory arthritides, inflammation and joint effusion, if present, is usually mild and localized to one or two affected joints."

    The ACR estimates that nearly 21 million Americans are living with OA and many are experiencing limitation in motion as a result. While the disease can affect any age group, it is more common among those over 45, and the incidence is expected to rise as the population ages. In fact, 70% of people over the age of 70 have X-ray evidence of the disease. However, only half ever develop symptoms. Women are affected more often than men, especially with OA of the fingers and the knees.

    A number of existing pharmaceutical products treat the pain associated with OA. The goal, according to the ACR, is to "include control of pain and improvement in function and health-related quality of life, with avoidance, if possible, of toxic effects of therapy." The U.S. osteoarthritis market is estimated to have annual sales of approximately US$4 billion. Of the many products on the market, most fall into one of the following categories:

    * over-the-counter oral medications that are accessible without a doctor's prescription, such as acetaminophen and low-dose NSAIDs (Advil®, Motrin®, Aleve®);
    * oral, full-dose, NSAIDs which are available only by prescription;
    *
    * oral COX-2 selective NSAIDs which are available only by prescription; and
    oral narcotics, such as opioid analgesics which are available only by prescription.

    Unlike these oral medications, Pennsaid® is a topical NSAID solution available only by prescription.

    New License Agreement with Covidien in the United States


    http://www.nuvoresearch.com/investor...0Agreement.pdf

    Nuvo Research Inc. (TSX: NRI) a
    Canadian drug development company focused on the research and development
    of drug products delivered to and through the skin using its topical and
    transdermal drug delivery technologies, today announced that it has entered into
    a license and development agreement with Mallinckrodt Inc., a subsidiary of
    Covidien (NYSE:COV), a leading global provider of healthcare products, granting
    it exclusive rights to market and sell Pennsaid®, and its follow-on product,
    Pennsaid Plus®, in the United States.
    Pennsaid and Pennsaid Plus are Nuvo’s topical non-steroidal anti-inflammatory
    drug (“NSAID”) candidates. Nuvo has been advised by the U.S. Food and Drug
    Administration (“FDA”) that it expects to respond to Nuvo’s resubmitted new drug
    application for Pennsaid by August 5, 2009.
    Under the terms of the license and development agreement, Nuvo will receive an
    up-front, non-refundable payment of US$10 million. In addition, Nuvo is eligible to
    receive a US$15 million milestone payment on Pennsaid’s approval by the FDA,
    which will increase to US$20 million if certain labeling criteria are agreed to by
    the FDA. Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid
    Plus at rates that are consistent with industry standards for products at similar
    stages of development. Nuvo will be eligible to receive additional escalating sales
    milestone payments for the products totaling up to US$100 million.
    Covidien will assume responsibility for all future development activities and
    expenses for Pennsaid Plus, including two Phase 3 clinical trials that Covidien
    expects to commence in 2010. Covidien has a right to negotiate with Nuvo on an
    exclusive basis for a period of 90 days to expand the licensed territory to include
    additional unlicensed countries worldwide. Nuvo will manufacture and supply
    Pennsaid and Pennsaid Plus to Covidien from its existing manufacturing facility
    in Varennes, Québec.
    Covidien is a leading global healthcare products company with revenues of
    nearly US$10 billion in 2008, and more than 41,000 employees in 59 countries
    worldwide. Its products are sold in more than 140 countries. A market study
    commissioned by Nuvo estimates that the market for topical NSAIDs will grow to
    US$2 billion annually within five years.
    “Covidien is an ideal partner with the infrastructure, market reach, resources and
    commitment to maximize the commercial potential of Pennsaid and Pennsaid
    Plus,” said Dan Chicoine, Chairman of Nuvo. “It is aggressively adding resources
    to maximize the value of the Pennsaid / Pennsaid Plus franchise and pursue its
    strategy of becoming a global presence in the treatment of pain.”
    About Pennsaid and Pennsaid Plus
    Pennsaid, Nuvo’s lead product, combines a transdermal carrier (containing
    dimethyl sulfoxide, popularly known as “DMSO”) with diclofenac sodium, a
    leading non-steroidal anti-inflammatory drug (“NSAID”), and delivers the active
    drug through the skin directly to the site of pain. Pennsaid Plus is the follow-on
    product candidate to Pennsaid. Pennsaid Plus will feature a twice-daily dosing
    regime as a gel formulation.

    Recent SP Action

    I bought in @ 0.25 a while back (NRIFF.PK), and since then, we have been up to 0.40 two times and back again (I wish I could have been at my computer to take advantage of this, but I did not see this coming the second time). Anyways, the opportunity has once again presented itself to get in at a decent SP before the pending FDA approval/rejection run-up. I think this is a BUY right now, but you may be able to squeeze a few more pennies out if you set your limits a little lower. I am holding at least to a couple of days prior to the FDA decision, and then I will most likely let my free shares ride it out. Note that this is a resubmission to the FDA 2006 approvable letter. This stock had a run-up to the 0.50-0.70 range prior to that FDA decision, and I fully expect it to happen again here, especially considering the recent licensing/development agreements. I believe this has a great chance for approval and Nuvo has given the FDA everything they had asked for in the past approvable letter. The Pennsaid phase III results are promising:

    Mississauga, Ontario, Canada – April 23, 2009 - Nuvo Research Inc. (TSX: NRI), a Canadian
    drug development company focused on the research and development of drug products delivered
    to and through the skin using its topical and transdermal drug delivery technologies, today
    announced that study results demonstrating that the Company’s lead product, Pennsaid, a topical
    non-steroidal anti-inflammatory drug (NSAID), is an efficacious treatment for the symptoms of
    osteoarthritis of the knee will be published in the June 2009 edition of PAIN.
    PAIN is the world’s leading publication on pain research and treatments and the official journal of
    the International Association for the Study of Pain (IASP®). The IASP, founded in 1973, is the
    leading professional forum for science, practice, and education in the field of pain and has more
    than 6,500 members in 118 countries who are professionals involved in the research, diagnosis and
    treatment of pain.
    The scientific article details Nuvo’s previously announced study results, which demonstrated that
    Pennsaid is efficacious for the relief of symptoms in patients with knee osteoarthritis. In addition, the
    study demonstrated that Pennsaid is as effective as oral diclofenac at relieving knee osteoarthritis
    symptoms but with less NSAID-related systemic toxicity. The article, titled, “Efficacy and safety of
    topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo,
    DMSO vehicle and oral diclofenac for knee osteoarthritis”, was written by Dr. Lee Simon as lead
    author, and Dr. Lisa Grierson, Zahid Naseer, Dr. Arthur A.M. Bookman, M.D., and Dr. J. Zev
    Shainhouse as co-authors. It is currently available on the PAIN website.
    “The publication of this article in the premier international pain journal further confirms Pennsaid’s
    unique and compelling efficacy and safety profile among all other topical NSAIDs,” said Dr. Brad
    Galer, Vice President and General Manager of Nuvo’s Pain Group. “This published data provides
    further support to our conclusion that Pennsaid, when approved by the U.S. Food and Drug
    Administration (FDA), will be the best-in-class product available in the United States.”
    Nuvo resubmitted its application for Pennsaid approval to the FDA in February 2009. The FDA has
    indicated that it intends to advise Nuvo of its decision regarding the approval of Pennsaid by August
    5, 2009 (the “PDUFA Date”) under the Prescription Drug User Fee Act.
    The subject of the PAIN article is Nuvo’s Phase 3 trial, Study 112, which enrolled 775 patients in the
    U.S. and Canada with symptoms of primary osteoarthritis of the knee. Patients in this five-arm,
    double-blind, 12-week trial applied a topical solution and took an oral pill. The five arms were: 1)
    Pennsaid plus oral placebo, 2) topical placebo containing a small amount of DMSO for blinding
    purposes (DMSO facilitates delivery of diclofenac to the knee) plus oral placebo, 3) topical vehiclecontrol
    (containing the same concentration of DMSO as in Pennsaid) plus oral placebo, 4) topical
    placebo plus oral diclofenac and 5) Pennsaid plus oral diclofenac.
    Pennsaid (arm 1) was superior to placebo (arm 2) with statistically significant improvement in all
    three primary clinical endpoints required by the FDA: pain relief (p=0.019), improvement in physical
    function (p=0.046) and improved patient overall health assessment (POHA) (p<0.0001).
    Additional results from the trial show that Pennsaid (arm 1) was superior to vehicle control (arm 3)
    (pain, p=0.009; physical function, p=0.026; POHA, p=0.016). There was no difference between
    vehicle control (arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective against the
    symptoms of knee osteoarthritis (p>0.05). There was no difference between Pennsaid (arm 1) and
    oral diclofenac (arm 4) for all three efficacy endpoints (p>0.05). Arm 5 was included in the trial at
    the FDA’s request to review the side effect profile of Pennsaid if combined with an oral NSAID.
    This combination showed no increased incidence of the usual systemic side effects, just the
    expected additive profiles of Pennsaid alone plus oral diclofenac alone.
    Dry skin was the most common adverse event with Pennsaid use. Fewer digestive system adverse
    events and laboratory abnormalities (decreased hemoglobin and increased AST, ALT and
    creatinine) were observed with Pennsaid as compared to oral diclofenac.

    Osteoarthritis is an ever-increasing ailment with the aging population, so this product has a significant market if approved in the US. Again, you may be able to squeeze out a couple of cents, but this is a buy regardless even at current prices, so do not wait too long. It is not often you are given the chance to enter three times (two pull-backs). Good luck.

    Darin
    Last edited by ChuckD; June 19th, 2009 at 08:40 PM. Reason: Added Tags

  2. #2
    Administrator Spinner's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Good call; this one is wallowing in the doldrums at the moment after some early (too early?) step rises, but I've no doubt it has a lot of upside potential before the end of July - I'm hoping for at least $0.65-$0.70 on pre-approval spikes (in which case I'll be covering my investment and riding free shares).

    Another article on the Covidien licensing agreement published today.

    Cheers, Spinner

    Disclaimer: Spinner is not a genius trader; postings are opinion, not advice. Twitter @iamspinner People are going to look back on SSW @ 10 and ING @ 6 and laugh.

  3. #3
    Captain Caveman GeeWillickers's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    I'm looking for over $0.80 and most likely will hold out for a $1 and take a long position as I can see this being 10 bagger in a year when sales start rolling in.

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    Power Broker Nauth's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    I really like this stock as well and I am currently holding onto 10k shares. I've found some nice tid bit of information about the stock if you'd like to follow up on it. This drug is already being used in the U.K and in Canada. it's called pennsaid and it's a cream. August 5th, 2009 is when we expect to hear from the fda.

    Third Time's A Charm For Nuvo Research (TSE:NRI), (PINK:NRIFF) |

    This is how i see it playing out. spike up to .60-.70 cents before fda date. Then the fda will post pone the approval of the drug which will drop the stock price back down to anywhere from .30-.20 and about 2-4 weeks later it get's approved and we see 1 dollar and above. I dont' really like it's chances for an actual approve on the time the fda annouces (so many biopharm companies are still wait even after fda dates) , plus this is a canadian company supply drugs to us citizens even though it would be marketed under a us company. However i think it would get approved later on becuase it has meet all the conditions that the fda wanted the first time it was rejected, and now a us company would be selling the drug to us citizens.

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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Nauth, this date is reasonable considering that the initial rejection issue was late 2006. They've been working with the FDA and I imagine independent consultants to deal with the labeling issues. As for the Canadian issue, I have to agree with you and another issue will be pricing differences between the two countries. Mind you what I've seen is it isn't cheap.

  6. #6
    Power Broker Nauth's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    The date maybe reasonable, but how likely do you think it will get approved on time?

    I think there is a 40% possiblility that it will get approved on time.

    I'd like to hear your thoughts on this G.W. in terms of % of it actually get's approved on time by the fda.
    Last edited by Nauth; June 20th, 2009 at 11:46 AM.

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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    It depends on what's going on with the FDA. How long will this backlog last? What new developments will the swine flu bring? The more stuff that happens the more backlogged they become. They seem to be shoving the little Bio Pharmas off to the side at the moment, and focusing on other projects.
    How long will it take the new director lady to get up to speed?

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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Topical pain relief has a huge market. I am holding 5000 shares and looking to buy another 5000 on dips, will look to sell half going into approval and if delayed, buy back at a lower price. If not delayed, Ill just ride the remaining half of the shares. Will look to book free shares for the long term as I think this company could see solid sales.
    May you live every day of your life~ Jonathan Swift

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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Quote Originally Posted by Nauth View Post
    The date maybe reasonable, but how likely do you think it will get approved on time?

    I think there is a 40% possiblility that it will get approved on time.

    I'd like to hear your thoughts on this G.W. in terms of % of it actually get's approved on time by the fda.
    Honestly have no clue or experience in these types of companies. The non-technical thing working against them is the total float of shares out there. As much as I'd like to see $1.50 it's just not practical but, that's also why we book free shares.

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    Power Broker Nauth's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    This stock is currently spiking Today!!

  11. #11
    Dog
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Are you American traders driving this up? Can't trade USA Bio today so taking a trip up north? Hmmm, something I'll take a look at on next holiday that doesn't coincide with ours...

  12. #12
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    IMHO someone big is working on accumulating a good size position.

    For the record I will let everyone know when I'm about to take the afternoon off, since my stocks seem to pop whenever the hell I'm not around.

  13. #13
    Pit Master schwi105's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Quote Originally Posted by GeeWillickers View Post
    Honestly have no clue or experience in these types of companies. The non-technical thing working against them is the total float of shares out there. As much as I'd like to see $1.50 it's just not practical but, that's also why we book free shares.
    I agree with this. $1.50 will be difficult to achieve, but you never know with the hype over these biopharm stocks lately. Everyone wants to make a quick buck. Anyways, I think a reasonable estimate could be a double from current levels prior to FDA approval, and following FDA approval, exceed the $1.00, potentially moving much higher on the spike. Who really knows, the market for osteoarthritis is large and growing, but many products already exist in this category. The main thing NRI has going for them is their transdermal delivery system and Pennsaid Plus being developed behind the scenes. We shall see soon enough.

  14. #14
    Pit Master schwi105's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Quote Originally Posted by GeeWillickers View Post
    IMHO someone big is working on accumulating a good size position.

    For the record I will let everyone know when I'm about to take the afternoon off, since my stocks seem to pop whenever the hell I'm not around.
    I also agree with this. It is/was only a matter of time before the big boys got involved, especially with the Covidien agreement and all. We are about a month out of the FDA's decision, which is when I expected a sustained spike to occur. I just hope we can hold these levels now and trade in the 0.40-0.50 range for a week or two before a 0.50-0.60 range the next couple of weeks after that. Could be some major money to be made playing the spikes and dips. Good luck to all. I am not sure about all this warrant business. I have yet to see consistent information on this. Personally, I hope the warrants were exercised and that a rumor brews behind the scenes, but a combination of good things rarely occurs simultaneously.

    Darin

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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    The reason for my skepticism on passing the $1.50 is the number of shares out there is pushing close to 400 million. A think a market cap of $600 million purely on news is being optimistic but, as you said for the long investor this stock would still most likely show them a 100% gain minimum within a year.

    I fence sat on Wednesday/Thursday and contemplated dumping AZD in order to acquire at another 50k to 75k to be able and hold between 25k and 50k for the long. May still do this next week depending on it's volatility.

  16. #16
    Pit Master schwi105's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    I found some more competition for the future:

    On 6/15/09, Transdel Pharma (TDLP.OB) ($1.40) announced that the Company anticipates reporting top-line results from their current Phase 3 study of Ketotransdel during 3Q09. The Phase 3 study consists of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug (NSAID), in acute soft tissue injuries of the upper and lower extremities. The multi-center trial is being conducted at approximately 30 sites in the U.S. and will enroll about 350 patients. TDLP plans to initially seek FDA approval of Ketotransdel for the treatment of acute pain and then expand the label to include additional indications such as osteoarthritis.

    TDLP is a long ways off yet though, so no worries short term. I never thought I would say this, but.....GO CANADA!!!!!!!

    Darin

  17. #17
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Hey thanks. There's more than enough market for multiple players. It certainly demonstrates the difference in pricing between the different exchanges.

    Just did rough calculations for Transdal at 15mil vs Nuvo at 350mil for shares for fun. Equivocally either Transdal should be at 6 cents a share or Nuvo at $10 based solely on share to share. It almost appears to me that a lot of these stocks are undervalued when compared with their US counterparts. Interesting to say the least.

  18. #18
    Pit Master schwi105's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    Quote Originally Posted by GeeWillickers View Post
    Hey thanks. There's more than enough market for multiple players. It certainly demonstrates the difference in pricing between the different exchanges.

    Just did rough calculations for Transdal at 15mil vs Nuvo at 350mil for shares for fun. Equivocally either Transdal should be at 6 cents a share or Nuvo at $10 based solely on share to share. It almost appears to me that a lot of these stocks are undervalued when compared with their US counterparts. Interesting to say the least.
    Yes, I am not sure why that is exactly, especially considering the stability of the Canadien economy compared to the US . It is an interesting phenomenon for sure. Well, let us just hope that when Nuvo enters the US market, its SP will climb to 'normal' US levels . That will not happen (although $10 would not be a bad rate of return), but may be factored in to some extent?

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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    So what are you guys thinking is a good entry point for NRI right now? After the double day drop off, the pps is certainly looking like an awesome point to get in.

    Anyone think the doom and gloom we're seeing this week will bust through the support we seem to be seeing at the 0.35 level? Personally, I don't think it will, and this two day rough patch has created another good opportunity to get in, or pick up more shares.

    Am I wrong?

  20. #20
    Administrator Spinner's Avatar
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    Default Re: NRI.TO NRIFF.PK Nuvo Research

    I would be very confident you'd see a positive return from $0.35 in the next month, and I'd agree is is unlikely to go much South of there until August, and only then if everything goes pear shaped.

    My next target on the sell ladder is $0.55 and I'd expect to see that by the end of July.

    I don't know how many shares you currently have, however, and wouldn't recommend overextending on any one bio at present, there are so many around between which to spread the risk.

    Cheers, Spinner

    Disclaimer: Spinner is not a genius trader; postings are opinion, not advice. Twitter @iamspinner People are going to look back on SSW @ 10 and ING @ 6 and laugh.

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