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diaDexus, Inc. Message Board

hofno2003 294 posts  |  Last Activity: 4 hours ago Member since: Jul 7, 2005
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  • 12 month share price target: 3-5 usd, here are the reasons why this is a fair target:

    - VICL has enough cash on hand (and no significant debt) to run the Herpes trial on its own cost for the next 2 years, actually about 0,5 usd per share ($50 million overall)
    - the HSV project, although in phase 1/2, represents a significant business opportunity; the potential market for such a therapeutic vaccine would be in the billions of usd and therefore should also contribute 100 - 200 million market cap as of today (1-2 usd per share); The trial will soon be fully enrolled and we will get early efficacy data in 2015
    - the CMV phase 3 project, partnered with Astellas for HSC also represents a significant opportunity and should be valued at least with 10-20% of the revenue potential (100 million usd = 1 usd per share)
    - the CMS phase 2 project for solid organ transplants should also contribute a market cap of 100 million usd / 1 usd per share.

    AND: technically the SP built a base in the range ob about $1.20. Once the uptrend starts we will get further support by short covering.

    So, overall we should see, with all discounts and conservatively estimated, a share price of 3,5 - 5,0 usd per share would be a reasonable target.

    hofno. THE BEST IS YET TO COME
    Long position in LPCN, POZN, ATRS, VICL, DSCI, GALE, RXII;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Oct 27, 2014 12:20 PM Flag

    Thanks. Will have a look at IDRA and MEIP.
    hofno

  • hofno2003 hofno2003 Oct 24, 2014 1:01 AM Flag

    nothing has changed concerning PA meanwhile Vimovo is protected with additional patents - everything is aligned, the manufacturing issue at Patheon will be resolved before PDUFA or is already resolved (and we will get an update on the next CC).

    hofno. THE BEST IS YET TO COME
    Long position in LPCN, POZN, ATRS, DSCI, GALE, RXII

    Sentiment: Strong Buy

  • Reply to

    Another 50k shares sold by CEO yesterday

    by daili800400 Oct 22, 2014 7:09 PM
    hofno2003 hofno2003 Oct 23, 2014 7:12 AM Flag

    Plachetka had no option to wait, because this was a preset and automated transaction based on a preset option exercise and trading plan according to Rule 10b5-1 of SEA 1934 long time ago. From the SEC-filing:

    """"""""""""""""""Option exercises and open market sales pursuant to a 10b5-1 trading plan adopted by the Reporting Person in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended."""""""""""

    Hofno. THE BEST IS YET TO COME

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Oct 22, 2014 4:28 PM Flag

    We have some interesting milestones ahead. New data concerning the progress of our preterm birth drug and news concerning FDA PDUFA formal decision on Clarus oral T on November, 3;

    hofno. THE BEST IS YET TO COME
    Long position in LPCN, POZN, GALE, RXII, DSCI, ATRS;

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Oct 22, 2014 10:03 AM Flag

    You are right - I only tried to demonstrate the potential of PA. For sure the royalty stream from Vimovo and Treximet should add $10-$15 to the share price target and support this level even in the absence of PA approval which will very likely happen in or before December 2014.
    Thanks
    Long position in RXII, LPCN, POZN, ATRS, GALE, DSCI;

    Sentiment: Strong Buy

  • Reply to

    PDUFA on December 30

    by hanshi_frank_dux Oct 21, 2014 11:07 AM
    hofno2003 hofno2003 Oct 21, 2014 1:31 PM Flag

    Yes, if we hear that Patheon's regained GMP compliance before, then the chance to get the approval is 95%.

    hofno. THE BEST IS YET TO COME
    Long position in LPCN, POZN, GALE, ATRS, RXII, DSCI;

    Sentiment: Strong Buy

  • Reply to

    Interesting

    by hiwatt1959 Oct 17, 2014 5:11 PM
    hofno2003 hofno2003 Oct 21, 2014 10:46 AM Flag

    The FDA agreed on efficacy endpoints and this is not the matter to worry about. BUT there is some material uncertainty about the safety data/endpoints and RPRX obviously doesn't know exactly what the FDA deems to be necessary - otherwise they would have provided the data and wouldn't have applied for a pre NDA meeting.

    hofno
    Long position in LPCN, POZN, RXII, ATRS, RXII, GALE;

  • Reply to

    Interesting

    by hiwatt1959 Oct 17, 2014 5:11 PM
    hofno2003 hofno2003 Oct 19, 2014 1:19 PM Flag

    you summarized it right. Androxal is for sure a viable product candidate but RPRX is very naive to nail it down and perhaps not only naive but agressive oriented towards positive sales spinning to secure the co's and managements short term survival and less obliged to scientific procedures and processes. This doesn't bode well for a stringent NDA approval process and destroys any real intrinsic value associated with Androxal.

    hofno

  • hofno2003 hofno2003 Oct 19, 2014 3:28 AM Flag

    I am no happy to be partially proven right, I don't like to loose money by myself or to see others loosing money.

    Although I meanwhile think that the company has a lot of safety data available - for sure they didn't submit sufficient safety data information with the pre NDA meeting request and they don't have a appropriate synopsis of the safety data until now. I will bet that we will not see a NDA this year.

    hofno.
    Long position in LPCN, DSCI, POZN, ATRS, GALE, RXII;

  • Reply to

    Interesting

    by hiwatt1959 Oct 17, 2014 5:11 PM
    hofno2003 hofno2003 Oct 19, 2014 3:03 AM Flag

    """Repros said Friday it doesn’t know why the FDA indicated the clinical information isn’t sufficient for a type B meeting. It noted, however, that synopses for the one-year DEXA safety study and the drug-drug interaction study, both of which it said may be significant to the FDA’s review, weren’t available at the time the briefing document was submitted to the FDA. """

    So, why wasn't a synopsis available in timely manner, and yes, your question is right: why did they request a type B meeting when they knew that both studies are critical for an FDA review and therefore a type B meeting? Handling a project management critical path tool and handling an NDA submission are really two different shoes and competences.

    hofno
    Long position in LPCN, RXII, POZN, ATRS, GALE, DSCI

  • Reply to

    Interesting

    by hiwatt1959 Oct 17, 2014 5:11 PM
    hofno2003 hofno2003 Oct 19, 2014 2:53 AM Flag

    Isn't a "Critical path" analysis something used in project management and project organization to demonstrate the interactions and dependancies of project events in order to get a clue about the most important tasks in a complex and high multitask project context, such as sending a rocket to the moon? (I think submitting a NDA isn't such a complex multitask process where you need to use critical path tools, JMHO). So the companies statement may be totally correct (but irrelevant), but this is no statement about quality of results or something like this which is more relevant for an NDA review and the FDA's decisions. But indeed, do you really need a "critical path analysis method" in this simple and very stright forward project to get your simple linear tasks aligned for submitting an NDA? I think such statements are strange at least (more a PR drivel) and do not generate much confidence concerning people associated with this.

    hofno
    Long position in LPCN, DSCI, ATRS, RXII, POZN, GALE;

  • hofno2003 hofno2003 Oct 13, 2014 1:24 PM Flag

    Fore sure every successfull clinical Ebola project will get new funds. Ebola will not be diminished within weeks, this is more a matter of years to contain the virus. But it is possible if all resources are combined and used ...

    hofno

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Oct 13, 2014 12:59 PM Flag

    They can be used. But if they are not "humanized" the animal antibodies will induce an human antibody reaction against the animal antibodies (within 5-7 days) which eliminates them and a second treatment will be without effect. But in the case of Ebola this doesn't matter much, because either the first treatment with antibodies is successfull or the patient has no chance for a second cycle of treatment.

    hofno

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Oct 13, 2014 11:41 AM Flag

    .... vaccine could be made ready very fast, all components are in place, ....

    hofno

    Sentiment: Strong Buy

  • Excerpt of an earlier VICL PR:
    Ebola DNA vaccine produces immune responses in all fully vaccinated volunteers in Phase 1 trial
    Vical Incorporated (Nasdaq:VICL) announced today that an Ebola vaccine candidate administered using Vical's proprietary DNA delivery technology was safe and well tolerated, and produced both antibody and T-cell Ebola-specific responses in all healthy volunteers who received the full 3 doses of vaccine.
    The Phase 1, randomized, placebo-controlled, dose-escalation study, the first human trial for any Ebola vaccine, was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and conducted at the NIH Clinical Center. The DNA vaccine used in the Phase 1 trial incorporates genetic material encoding core and surface proteins from two strains of Ebola. Vical has secured a nonexclusive license from the NIH to proprietary gene sequences used in the vaccine.
    "The high rates of immune responses at all dose levels in this initial human Ebola vaccine study support continued development of this vaccine and further evaluation of our technology for potential additional biodefense and emerging disease applications," said David C. Kaslow, M.D., Vical's Chief Scientific Officer, "particularly where antibody responses may be protective. Our processes allow rapid development and manufacturing of vaccines without handling potentially dangerous pathogens."
    The vaccine used in the Phase 1 trial vaccine included three plasmids (closed loops of DNA), one each encoding the surface glycoprotein (GP) from the Zaire strain of Ebola, GP from the Sudan/Gulu strain, and the internal nucleoprotein (NP) from the Zaire strain. Subjects received three doses of vaccine or placebo at one-month intervals via intramuscular needleless injection. Ebola-specific antibody responses against at least one of the encoded antigens were detected in all vaccine recipients. ......

    Sentiment: Strong Buy

  • hofno2003 hofno2003 Oct 11, 2014 2:53 AM Flag

    A deal at $250 million upfront payment would result in $8 per share. Isn't this crazy? Whats wrong?

    hofno. THE BEST IS YET TO COME
    Long position in POZN, ATRS, DSCI, RXII, GALE, LPCN;

    Sentiment: Strong Buy

  • If I get it right POZN has all rights for developing and marketing of Treximet outside US and is in talks for a licencing deal. In a PR and their Q2 CC they stated that, once Pernix closes the Treximet deal with GSK for US, they (POZN) have regained all rights for Treximet outside US and will seek for a licencing deal.

    Just to get a clue about the potential deal value I would like to refer to a special detail of the GSK-Pernix-Treximet US deal:
    ".....Pernix has made an upfront payment to GSK of $250 million for the U.S rights to Treximet® ....."

    So, I think it is reasonable to think the deal value for POZN with Treximet licencing in EU has the same potential. Thats really great and - I have to admit - is far beyond what I thought before. Treximet is a hidden gem in the pozen deal pipeline.

    hofno. THE BEST IS YET TO COME
    Long position in LPCN, POZN, ATRS, DSCI, GALE, RXII;

    Sentiment: Strong Buy

  • Reply to

    Anturol Scripts this week were 895!

    by daviscupper Oct 10, 2014 3:44 PM
    hofno2003 hofno2003 Oct 10, 2014 4:02 PM Flag

    Antares Anturol taps a $2 billion market for OAB.

    OAB, also called urge incontinence, is a condition marked by a sudden need to urinate that can happen at any time whether or not the bladder is full. OAB is typically caused when the smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage. OAB is defined as urgency, with or without urge incontinence and usually includes frequency and nocturia (waking up one or more times during the night to urinate). According to published reports it is estimated that more than 30 million Americans have OAB, and while it can happen at any age is more prevalent among older individuals. It is more common than both diabetes and asthma. According to IMS the annual OAB prescription market in the United States is valued at approximately $2.0 billion.

    hofno THE BEST IS YET TO COME

    Sentiment: Strong Buy

  • Reply to

    Now we have good results on Phase 2a.

    by orchids3333 Oct 7, 2014 7:26 PM
    hofno2003 hofno2003 Oct 9, 2014 5:19 AM Flag

    Just to be clear: SPA = Special Protocol Assessement. This means that all primary and sec. efficacy endpoints as well as potential safety endpoints for a final approval are preagreed with the FDA before a phase III trial starts. This is an important agreement, because it derisks the FDA review process for an NDA. If you met all SPA endpoints - you get your approval. If you missed it - you don't need to file for approval.

    hofno. THE BEST IS YET TO COME
    Long position in LPCN, RXII, POZN, DSCI, ATRS, GALE;

    Sentiment: Strong Buy

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