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Joe Gantoss
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Technical Analysis & Japanese Candlesticks Trader as a full time job, over 15 years of experience, combining with fundamentals and thorough DD to find the best entry & exit points, Biotech sector expert, following this sector for over 4 years, trading the clinical catalyst &... More
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  • $BPAX Technical Analysis - Looking for direction.
    $BPAX had a great run-up started @ $2.50 mid of June till it reached the high of $4.02 on 07/13 creating a "Dark Cloud Cover" a bearish pattern, giving the first sign that the technical correction is coming, followed by several doji's to insure the confusion of the investors about the direction.
    The correction break down the first support level @ $3.20 level heading to the second & strong support around $2.50 that used several times in the past as a support & resistance point...and with the help of the markets bearish sentiment during the "Debt Ceiling" issue followed by the markets sell-off, $Bpax price dropped toward the $2.00 level finding the 200MA as a support level.
    The price break down a LT (long term) uptrend line and the 200MA but bounce back creating a Bullish Hammer as a reversal pattern followed by 3 doji's and a long green candlestick last Friday checking the resistance line @ $2.50 but closing below the line, I believe that the trend will continue and breakup the $2.50 level heading towards the second resistance line @ $3.20

    We can see that all the indicators are in the oversold zone, that gave us a hint for the direction as an uptrend is coming, but we have to give more weight to the "Markets Sentiment" as in this case the markets can put a pressure @ the biotech sector and dragging $Bpax with it for a new downtrend.

    Keep watching closely.
    Disclosure: Long Bpax

    For more Technical Analysis for the biotech stocks visit
    joebiocharts.blogspot.com/



    Aug 15 1:22 PM | Link | Comment!
  • PROTALIX Submits Reply to FDA CRL as my evalutaion
    In the first article that I wrote about PROTALIX early July I stated:
    "I am confident that PROTALIX is close to the resubmission.  I believe that the Company will be able to address all of the requests the FDA had asked for in their complete response approximately near the end of July until mid-August.

    Today August 01st PROTALIX Submits Reply to FDA Complete Response Letter for Taliglucerase Alfa and Reports Top-Line Results from the Company's Switchover Trial.

    The Company's submission addresses the issues identified by the FDA in the Complete Response Letter, including the request for clinical data from the Company's switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls (NYSE:CMC).

    Data from all twenty six adult patients enrolled in the Company's switchover trial of patients switched from Cerezyme® to taliglucerase alfa over the nine-month period, were included in the submission. The data supports the efficacy and safety data package showing that patients can be switched from imiglucerase (Cerezyme®) to taliglucerase alfa. One patient experienced a hypersensitivity reaction. The efficacy data demonstrates that mean hemoglobin and platelet count, spleen volume and liver volume remained stable. Patients enrolled in the trial were switched from imiglucerase (doses ranging from around 10-60 U/kg every other week) to an equivalent dose using the same number of units of taliglucerase alfa.

    The submission also included data from treatment naïve patients who completed the Company's pivotal Phase III trial and have continued to receive taliglucerase alfa for over 24 months in the Company's blinded long-term extension trial. These patients continued to show an improvement in efficacy and the drug was safe and well tolerated. Furthermore, those patients who were followed specifically for their bone parameters using Quantitative Chemical Shift Imaging
    (QCSI) MRI continued to show bone marrow improvement over time. Detailed data from the Company's switchover trial and long-term extension trial will be presented at upcoming medical meetings.

    Regarding CMC, Protalix submitted further analyses and modifications of analyses previously submitted to the FDA to address their questions raised with regard to testing specifications and assay validation.

    After the resubmission completed, PROTALIX expects the FDA to provide an updated Prescription Drug User Fee Act (PDUFA) target action date within 14 days.
    The FDA review team and division director will determine the classification of the
    response, and a letter will be issued to the applicant acknowledging receipt of the
    resubmission within 14 calendar days stating the classification of and the due date for action on the resubmission.

    Class I is a two month review from the date of submission
    Class II is a six month review from the date of submission

    I anticipate that PROTALIX will get a Class II resubmission according to the data that was requested by FDA. If they receive a Class I resubmission, it may benefit shareholders significantly since there is less time to discount the event of possible approval.

    I received so many emails and direct messages asking me, if PLX got Class-II, is it going to suffer a sell off too? The same as we usually see in the Biotech land these days.
    I think that there will be no sell off, or a small action of profit taking, as most of the investors following PLX are a long term investors, and most of the biotech retail investors that usually following the catalyst run up, leave after it's done and jump to the second play, most of them already left the short term trade during the market volatility and shake out waiting for the debt ceiling issue to be solved.

    As most of these investors already know that most likely Protalix will get Class-II review, so will be no surprise at all, and only the investors that believe on Protalix's potential will keep holding, knowing that beside the FDA review there is the European and the Brazilian review too, both are a real catalyst by themselves.

    I will keep holding PLX through the decision, and wait till the PDUFA date, Technically we can see a solid support around $6.20, and if there will be a profit taking, I don't think that the price will break out this support level, in the other side, we know that Protalix can run up very fast to the $10 - $11 levels, as already did last year, and the resubmission is much safer than the first PDUFA and PLX most likely get the FDA approval.

    Disclosure: Long PLX

    Tags: PLX, Biotech
    Aug 02 12:19 AM | Link | 3 Comments
  • Protalix Major Shareholder Biocell To Maintain Holding.

    Today July 18th the shares of Protalix are down about 7% due to a July 17 report by the Israeli Business Globes website related to PLX's largest shareholder, a holding company called Biocell Ltd.


    The conflict started as the shares price of Biocell (trading in TASE the Israeli market) keep dropping, and Biocell have no activity unless holding 17% of Protalix shares, but their price that used to follow Protalix prices start move in other direction leaves the shareholders of Biocell with a huge losses, in the last two months, Biocell Shareholders start asking the management for a liquidation of the company and the distribution of its Protalix shares as a dividend in kind. Shareholders have been pressing the company to either liquidate or change its conduct. The Protalix holding is the company's sole interest, and investors say that they should own Protalix directly, and that there is no justification for the salaries of Biocell's managers and directors. Biocell's directors rejected the shareholders' arguments. The directors' argue that liquidating the company would severely affect the value of its holdings, because Protalix's value is partly based on future improvements and looking for upgrades of Protalix as they are very close for the NDA resubmission .

    I had a chance to discuss this with Protalix IR (Investor Relations) and they see this as a positive development as it limits the potential for any near-term non fundamental disruption for PLX from a share sale. We had a similar case to what had been observed with ITMN when largest holder Warburg Pincus recently liquidated its position. In case and Biocell will make the distribution to Biocell shareholders, so we can see a potentially only 10-20% of the shares needing to be sold on the open market to cover taxes. Protalix's future and main catalyst is the taliglucerase NDA resubmission that will be in the next few weeks and U.S., Brazilian, European, and Israeli regulatory approvals potentially later in Q3- Q4 2011. And only this catalyst will drive the price of Protalix , I can see the shares price at this levels around $6.20 - $6.50 definitely a good buying opportunity.

     

    Disclosure: Long PLX

    Tags: PLX, Boitech
    Jul 18 2:21 PM | Link | Comment!
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