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  • Pharmacyclics Is Not Worth $51.30 With No FDA Approved Drug. Ideally Its Should Be Below 10

    Pharmacyclics Inc. (Nasdaq: PCYC) is a clinical-stage biopharmaceutical company focused on discovering and developing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Below is the chart that shows its product pipeline.

    (click to enlarge)
    Pharmacyclics Pipeline

    As seen from the product pipeline chart, PCYC has no product in Phase 3 and it takes approximately 1.5 year to get FDA approval and sales and marketing of any product to generate any revenue. Revenue for the fiscal quarter ended September 30, 2012 was $102.7 million, compared to $37,000 for the fiscal quarter ended September 30, 2011, an increase of approximately $102.7 million. Revenue for the fiscal quarter ended September 30, 2012 consisted primarily of $100 million of license and milestone revenue due to the Company's achievement of two clinical milestones in connection with the Company's collaboration and license agreement (the "Agreement") with Janssen Biotech, Inc. ("Janssen").

    To date, $150M in milestones have been earned and Pharmacyclics may receive up to an additional $675 million in development and regulatory milestone payments; for total potential upfront and milestone payments of $975 million.

    Following regulatory approval, both Pharmacyclics and Janssen will book revenue and co-commercialize ibrutinib. In the US, Pharmacyclics will book sales and take the lead role in US commercial strategy development. Both Pharmacyclics and Janssen will share in commercialization activities. Outside the United States, Janssen will book sales and lead and perform commercialization activities. Profits and losses from the commercialization activities will be split 50/50 on a worldwide basis. Development and commercialization activities under the collaboration will be managed through a shared governance structure. Each company will lead development for specific indications as stipulated in a global development plan, with development costs shared on a 40/60 basis (Pharmacyclics 40% and Janssen 60%).

    (click to enlarge)
    PCYC should be less then $10 ideally with no FDA approved drug

    Based on the chart, PCYC has moved moved up 246% in 2012, 90% in last 6 month and 2403% in 5 year.

    In Nov 2009, it was $1.85 A pharma company without FDA approval of any product is worth less then $10 in reality.

    Tags: PCYC, BMRN
    Nov 05 8:40 PM | Link | Comment!
  • IS SAREPTA THERAPEUTIC (SRPT) WORTH $44.93 ?

    http://www.freefdawatchlist.com/2012/10/is-sarepta-therapeutic-srpt-worth-4493.html

    Sarepta Therapeutics (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today announced that treatment with its lead exon-skipping compound, eteplirsen, met the primary efficacy endpoint, increase in novel dystrophin, and achieved a significant clinical benefit on the primary clinical outcome, the 6-minute walk test (6MWT) over the placebo/delayed treatment cohort in a Phase IIb extension trial in Duchenne muscular dystrophy (DMD) patients. The company changed its name from AVI BioPharma in July. Here is a link http://investorrelations.sareptatherapeutics.com/phoenix.zhtml?c=64231&p=RssLanding&cat=news&id=1741044

    Now here is the highlight of the study.

     

    • "Study 4658-US-201 was conducted at Nationwide Children's Hospital in Columbus, Ohio. Twelve boys meeting the inclusion criteria being between 7 and 13 years of age with appropriate deletions of the dystrophin gene that confirm eligibility for treatment with an exon-51 skipping drug, received double-blind IV infusions of placebo (n=4), 30 mg/kg of eteplirsen (n=4), or 50 mg/kg of eteplirsen once weekly for 24 weeks (n=4). Muscle biopsies for evaluation of dystrophin were obtained at baseline for all subjects, and after 12 weeks for patients in the 50 mg/kg cohort and after 24 weeks for patients in the 30 mg/kg cohort.Two placebo patients were randomized to the 30 mg/kg cohort and two placebo patients were randomized to the 50 mg/kg cohort. This study design allowed Sarepta to investigate the relationship of dose and duration of eteplirsen treatment on the production of dystrophin over the course of the 24-week study."
    • Sarepta Therapeutics' Lead Therapeutic Drugs for Ebola and Marburg Viruses Receive FDA Fast Track Designation but U.S. government has terminated the funding for Ebola. Because of this Sarepta anticipates 2012 full year revenue will be in the $37 to $43 million range and operating loss will be in the $25 to $30 million range. For the year 2011, the operating loss was $35.9 million, compared to an operating loss of $20.9 million for the prior year.
    • SRPT doesn't have anything in Phase 3. Here is a pipelie of R&D. It takes atleast 1 year trial in phase 3. It takes approximately 1 month for FDA to accept application and give approval date which would be minimum 6 month. That means SRPT will not be in the market for sale till next 2 year unless FDA approves it.
    (click to enlarge)
    R&D pipeline for SRPT
    • Based on the cash balance for R&D work and no drug in phase 3, SRPT doesnt look like its worth even $10.
    Tags: SRPT
    Oct 04 9:20 AM | Link | Comment!
  • STOCKCHARTS: IDCC, PCLN, PPHM, DNKN, FAS,AAPL, RIMM, TPX

    Based on the chart, here are new price target (PT) for IDCC, PCLN, PPHM, DNKN, FAS, AAPL, RIMM, TPX, and KOG. Here are some of my best prediction posted last week QCOR, ANR, PNRA, LQDT, ULTA. http://www.freefdawatchlist.com/2012/09/some-of-best-prediction-chart-qcor-anr.html

    IDCC new PT = 34.80

    (click to enlarge)
    IDCC short term PT of 34.80

    PCLN New PT 594

    (click to enlarge)
    PCLN short term PT 594

    PPHM new PT 0.90

    (click to enlarge)

    AAPL New PT 649

    (click to enlarge)
    AAPL new PT 649

    DNKN PT 27.95

    (click to enlarge)
    DNKN new PT 27.95

    KOG new PT 8.86

    (click to enlarge)
    KOG new PT 8.86

    TPX new PT 28.85

    (click to enlarge)
    TPX PT 28.85

    RIMM new PT 7.13

    (click to enlarge)
    RIMM new PT 7.13

    FAS new PT 97.96

    (click to enlarge)
    FAS PT 97.96

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Sep 30 2:25 PM | Link | Comment!
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