Wedbush upbeat on Northera panel despite FDA staff review


Wedbush is out in defense of Chelsea Therapeutics (CHTP -31.3%) amid a steep sell-off triggered by the release of Northera briefing docs.

"The reviewers brought up no material new arguments against approval, in our view," analyst Liana Moussatos says, adding that "the previous panel recommended approval (7-4) —so we anticipate the panel on January 14th is likely to also recommend approval."

Price target is $8.

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Comments (20)
  • Jolly_Rancher
    , contributor
    Comments (623) | Send Message
     
    That MAY be true, but by the same token the FDA is still saying it does not want to approve.
    10 Jan 2014, 01:43 PM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    There is something I don't understand. This morning several websites mention that the Northera review was published on the FDA site. But there I can find it nowhere, where ever I look. Entering Northera in the searchbox show older articles and January 14. Nothing about today.
    10 Jan 2014, 02:07 PM Reply Like
  • sdshinabarger
    , contributor
    Comments (2) | Send Message
     
    Not that it explains your comment but: http://bit.ly/1lJRAYs
    10 Jan 2014, 04:50 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
     
    Mr. H Neumann: The FDA is part of the government. Do you actually expect them to keep updating their websites daily? Call Sebelius and let her know about this right away!!!
    10 Jan 2014, 02:18 PM Reply Like
  • fedora888
    , contributor
    Comments (29) | Send Message
     
    Useless and pointless reply.
    10 Jan 2014, 03:26 PM Reply Like
  • P Man
    , contributor
    Comments (1485) | Send Message
     
    No official review as taken place. The only thing that has happened is the briefing book was released. This is a document that is to guide the discussion at the panel meeting. It is not an outcome - it is a look into what the FDA is concerned about and would like discussed at the meeting.
    10 Jan 2014, 04:01 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
     
    True, but why can't I be useless and pointless? In this world I think we need a little more humor, and even you personally don't think it's funny that's not my problem.
    10 Jan 2014, 04:41 PM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    Ok, but I wrote that other websites (newsagency Reuters f.i.) got their info from the FDA website. So apparently it is there. From another SA publishing recently I understand that it is the document with the date January 14th where the information comes from. That it what confused me, because I was looking for Northera January 10th news.
    10 Jan 2014, 02:26 PM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    The documents seem to mention: "FDA staff list five arguments in favor of approval and seven against approval." So I don't know why Liana from Wedbush is optimistic.
    10 Jan 2014, 02:29 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
     
    I don't know why she is optimistic either. Maybe Wedbush has some vested interest in keeping people in the stock. I put in a Stop Market Buy order 1 hr before closing yesterday at 10% above the price thinking I would be OK and not buy until after this mornings announcement. The price went up 10.56% and I ended up having my order filled right before the market closed. I was hoping to not buy if the price went down but get in on the upswing if it took off. It was a bone-headed bad luck experience. I do hope Tuesday's news is better since at this point I will hold and take my chances since I'm already down 25%. Fortunately, my other stocks have more than made up for the loss today. This week has been the best ever! Portfolio up 15% this week.
    10 Jan 2014, 02:48 PM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    I planned to do the about the same, stop limit buy order $ 0,20 higher, but decided to wait until today. What I also planned was a stop limit sell order to go short, but didn't do that either. This morning I was caught by surprise, didn't think the review would come out that early. I wish you luck next Tuesday. With which stocks did you win ? I made some money with XONE, MU and ZLCS this week.
    10 Jan 2014, 03:26 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
     
    To: HN My biotech portfolio is: ACRX up 35%, CGIX up 62%, CHTP dn -25%, CLDX dn -5%, CTIC up 40%, CYNAF up 101%, CYTR up 15%, GALE up 190%, HALO up 33%, NWBO dn -4%, SNTI dn -19%, TNXP up 117% and XOMA up 28% since I bought them. These gains have been in the last 2 months. 30 to 40% up on average in both Nov and Dec. 9 up and 4 down. I have sold a couple of other losers and took some profits but mostly I've bought these and are holding for now.
    10 Jan 2014, 06:00 PM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    Thanks russleehowe. And your strategy is buy well in advance of FDA decisions ?
    10 Jan 2014, 07:26 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
     
    Yes, I look for stocks that have numerous products in development, usually (CHTP has one good possibility, I hope.) I look for stocks breaking out on high volume, which indicates the big money is moving in or when they get some sort of big PR push so that more people start following or buying, like TNXP did with Joe Springer or NWBO in Fox Business (up 75% in a couple days -- I bought very low and sold at 75% gain in 3 days. Stock retreated & I bought again but it hasn't gone anywhere since). All stocks are anywhere from micro cap to low mid cap. No big caps. Usually too big to grow really fast. I also have 15 stocks in this portfolio. Spread the $ to reduce risk. Get rid of stocks that go down or don't go up (usually). Asymetic investing: big potential gain with small potential loss. I $2 stock can only lose $2 but gain an "infinite" amount. I don't usually look at the stage of development. Most of the big investors, like Baker Brothers, don't jump in and out constantly. Look at their list of stocks they own. Follow the money. I hope you get rich!!!
    11 Jan 2014, 08:26 AM Reply Like
  • Dean Plassaras
    , contributor
    Comments (102) | Send Message
     
    Out of curiosity. In the overall universe of FDA decisions, do you know how many end up as approvals and how many as rejections? What's the approve to fail ratio?
    11 Jan 2014, 01:05 PM Reply Like
  • spoutingrock
    , contributor
    Comment (1) | Send Message
     
    @russleehowe A $2 stock can only lose $2...things that make you go hum????
    11 Jan 2014, 01:07 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
     
    A very Zen-like answer that I am not sure I understand. The point is, for example, JAZZ was $1 four years ago and it's $153 now and PCYC was $1 four years ago and it's now $122. One big winner like that can compensate for a lot of losers. Spread your risk and hope for the best. Of course, if a stock starts to tank get rid of it before it goes under. Keep on humming!!!
    11 Jan 2014, 03:14 PM Reply Like
  • hneumann
    , contributor
    Comments (630) | Send Message
     
    "I look for stocks breaking out on high volume, which indicates the big money is moving in or when they get some sort of big PR push so that more people start following or buying,"

     

    russleehowe, and on what website you follow high volume break outs ? Also on Twitter, like from A-C investor ?

     

    " A $2 stock can only lose $2 but gain an "infinite" amount."

     

    True, but that means that you buy not a lot of shares, let's say minimum 100, not more than 500 ?
    12 Jan 2014, 07:56 PM Reply Like
  • russleehowe
    , contributor
    Comments (80) | Send Message
     
    I use IBD (Investor's Business Daily). I subscribe to the online http://bit.ly/1af5vkj and the online newspaper http://bit.ly/1af5vkl Also, they have a service that I find virtually indispensable called MarketSmith. http://bit.ly/1af5tJl I think you can get it for free for a two week trial. These sources, especially MarketSmith, will give you a huge amount of data on all stocks. I don't work for them or get anything out of referring anyone. Just saying.

     

    I was using $2 as an example. But most of these biotech stocks are low priced. My portfolio of biotechs right now runs from $0.89 to $23.30. The bigger, more established companies are usually higher priced. I bought CYNAF at 0.44 and it is now 0.89 after only a couple of weeks (up 101% but that was lucky). I stumbled onto to it on SA. I like SA and get really good ideas here. I have about 15 of these small biotechs -- more on what seems less risk like XOMA (at $850 million mkt cap) and less on really tiny companies like CANF ($42 million mkt cap). Buy what you can afford even if it's only $500 or so per stock. Don't bet the farm of course but you might be able to buy one by investing in biotech. Medical/Biotech is now listed at the #1 category out of 197 groups of stocks. Higher ranked groups do better going forward because that's where the money is going. I also look at Baker Brothers. I think they only invest in biotech. They have a huge portfolio of over 60 stocks worth over $4 Billion. I figure they're a lot smarter and informed than I am. So you could start by looking at that list and then do your research.

     

    I am not a financial adviser or stockbroker and I'm not recommending any stock. Just responding to your questions and sharing ideas.
    12 Jan 2014, 08:42 PM Reply Like
  • lakeshow5
    , contributor
    Comments (17) | Send Message
     
    Russleehowe

     

    I love the positions you have taken. I have ACRX (3%), CHTP(-35%), CLDX(10%), HALO(10%) and XOMA(49%). I couldn't pull the trigger on TNXP when it was at 12 and it hasn't stopped going up. Same with CYTR at 5, thought I would have more time to buy both of those.

     

    I also recently took positions, (sometime in last 2-3 months), in BCRX (55%), CUR, KERX, MACK, PGNX(20%), SCMP(12%), ONTX, MNKD(15%).

     

    Also, an ETF I love is IBB(20%). On fire all year.

     

    We should collaborate. Seems like we like a lot of the same stocks and find them using different resources.

     

    Either way, cheers and GL
    14 Jan 2014, 06:25 AM Reply Like
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