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Theodore Cohen  

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  • Dynavax: New Phase 3 Clinical Study Finalized For HEPLISAV [View article]
    The trading on Monday, in light of the announcement today, is indeed interesting. I have alerted FINRA as well as Sen. Grassley's office. I would be very surprised if the leak came from someone within Dynavax Corporation, but stranger things have happened. The questions are: who was involved at Dynavax and Cowan, what did they know and when did they know it, and to whom did they speak?

    Ted

    T
    Oct 24, 2013. 09:38 PM | Likes Like |Link to Comment
  • Dynavax: New Phase 3 Clinical Study Finalized For HEPLISAV [View article]
    Sorry, I haven't been following AEZS.

    Ted
    Oct 24, 2013. 04:29 PM | Likes Like |Link to Comment
  • Dynavax Crashes On Unexpected Panel Vote [View article]
    http://seekingalpha.co...

    Here is the latest news.

    Ted
    Oct 22, 2013. 02:39 PM | Likes Like |Link to Comment
  • Dynavax: New Phase 3 Clinical Study Finalized For HEPLISAV [View article]
    Could be a major seller liquidating his position...or the stock breaking back below resistance. Difficult to say. There was no news.

    DVAX is a developmental stage company. It has no products. Further, it's not unusual for it to take many years to bring something through the FDA's approval process. I would hardly classify it as a jail sentence with no chance for parole. Sounds to me, if you are looking to invest in the pharma area, that you should be putting your money in companies with more mature pipelines and, perhaps, some products already on the market.

    Ted
    Oct 21, 2013. 05:49 PM | 1 Like Like |Link to Comment
  • Dynavax: New Phase 3 Clinical Study Finalized For HEPLISAV [View article]
    It's a very speculative play, to be sure...you'd have to be willing to wait until at least 2015--perhaps 2016--to learn whether or not Heplisav will make it to the US market.

    Ted
    Oct 21, 2013. 07:59 AM | Likes Like |Link to Comment
  • Dynavax: New Phase 3 Clinical Study Finalized For HEPLISAV [View article]
    Let's just say it's higher than the current price and leave it at that.

    Ted
    Oct 19, 2013. 03:42 PM | Likes Like |Link to Comment
  • Dynavax: New Phase 3 Clinical Study Finalized For HEPLISAV [View article]
    Well, Peter, there's certainly something to say about the FDA and hypocrisy, that's for sure. I found it interesting that one of the biggest stinks raised at the November advisory committee last year had to do with the racial distribution of the participants in the DVAX trials--remember how upset some members of the committee became after the chair, Dr Daum, poisoned the well?--and yet, there was nothing (NOTHING) in the CR letter DVAX received that mentioned this issue.

    But that said, the FDA is gunshy of adjuvants, and so, having had the advisory committee raise the question of safety, the agency clearly decided that additional safety data were called for.

    The issue you mentioned--adverse side effects and, specifically, those observed during a trial of the size that will be conducted--was addressed with the FDA during the discussions pertaining to the protocols for the new trial and how the data would be evaluated vis-à-vis the approval of HEPLISAV. Rather than repeat it here (possibly with errors), I urge you to listen both to the company's presentation this morning as well as one particularly detailed answer to an analyst's question that addressed the issue you raised. You can find the replay here:

    http://bit.ly/XRk9I8

    Issues pertaining to safety can, to some extent, be handled statistically. Consider: for rare events, you could run a trial of 25,000 patients and not encounter the event of interest whereas a trial of 25,001 might reveal the adverse event for which you are looking. Clearly, both the FDA and the company came to the conclusion that an additional trial comprising 5,500 HEPLISAV patients, together with the data already collected on HEPLISAV, will provide the safety data the agency needs to move the BLA forward.

    Ted
    Oct 17, 2013. 01:17 PM | Likes Like |Link to Comment
  • Dynavax: New Phase 3 Clinical Study Finalized For HEPLISAV [View article]
    They have enough cash, but I suspect will be raising cash over the next year. The CC announced now is in progress...you may want to tune in:

    http://bit.ly/XRk9I8

    Ted
    Oct 17, 2013. 08:40 AM | 2 Likes Like |Link to Comment
  • 4 Biotechnology Stocks With Room To Climb [View article]
    Nice overview...and thanks for the citation.

    Ted
    Oct 15, 2013. 09:32 AM | 1 Like Like |Link to Comment
  • Pimavanserin: The Most Underestimated Blockbuster In Biotechnology [View article]
    Well thought-out piece, Brian. Thanks for the insights.

    Ted
    Oct 14, 2013. 09:57 AM | 6 Likes Like |Link to Comment
  • Dynavax Initiates Phase I Trial In Its Asthma Program [View article]
    It will take a while to ramp up in the face of competition. I don't think they will be profitable for several years.

    Ted
    Oct 12, 2013. 08:33 AM | Likes Like |Link to Comment
  • Dynavax Initiates Phase I Trial In Its Asthma Program [View article]
    rockets12,

    Here are some sites in which you may have an interest:

    http://bit.ly/1gx9Mlm

    The study about which you inquired actually is being conducted by the Oklahoma Medical Research Foundation, under which it is listed (vice Dynavax). The study is currently recruiting, as far as I can determine.

    Dynavax Technologies Corporation, Protocol DV7-SLE-02. A Dose-Escalation, Multi-Center Study to Evaluate the Safety, Tolerability and Proof of Mechanism of DV1179 in Subjects with Systemic Lupus Erythematosus. (Currently Recruiting)

    http://bit.ly/1gx9Mlo

    Clinical Trials - Oklahoma Medical Research Foundation

    omrf.org › Patient Studies › Lupus (SLE)‎

    ... Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE). ... Dynavax Technologies Corporation, Protocol DV7-SLE-02. ... Proof of Mechanism of DV1179 in Subjects with Systemic Lupus Erythematosus.
    Oct 11, 2013. 03:30 PM | Likes Like |Link to Comment
  • Dynavax Initiates Phase I Trial In Its Asthma Program [View article]
    That's a good question. There were two studies of interest...both would have been performed by GSK. Here is the list of relevant studies from the FDA's site for GSK:

    http://1.usa.gov/19ET6aw;lup_e=

    Among the 29 must be the proof-of-mechanism clinical study of DV1179 in systemic lupus erythematosus (SLE) patients. Please share with us anything you find.

    Ted
    Oct 11, 2013. 08:36 AM | Likes Like |Link to Comment
  • Dynavax Initiates Phase I Trial In Its Asthma Program [View article]
    Not a problem. Anytime.

    Ted
    Oct 10, 2013. 06:09 PM | Likes Like |Link to Comment
  • Dynavax Initiates Phase I Trial In Its Asthma Program [View article]
    Sure, Arthur...take a look at this site;

    http://1.usa.gov/XIVgxq

    Ted
    Oct 10, 2013. 05:28 PM | 1 Like Like |Link to Comment
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