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Theodore Cohen

 
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  • What's Up With Vical? [View article]
    Here are the amended Form 4/A's

    http://bit.ly/1aFNIDw

    Not hard to get it right the first time! Really a botched job, to be sure!

    Ted
    Jan 16 07:59 AM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    The military trial data has not been released.

    Ted
    Jan 16 07:54 AM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Still, it was coded 'P,' which is confusing. Again, if it was linked to a bonus, this may explain the coding.
    Jan 16 07:53 AM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Questions have been raised as to whether or not the transactions were coded properly, as I noted below. You will note they were coded as 'P.'

    Transaction Codes

    Each transaction listed on the Form 4 filing has a transaction code:

    General Transaction Codes
    P – Open market or private purchase of securities

    http://bit.ly/1ajrSWm

    If these had been options that were exercised, with only the taxes paid, they should have been coded "A:"

    Rule 16b-3 Transaction Codes
    A – Grant, award, or other acquisition

    These 'grants' may have been in lieu of cash bonuses, which is why they may be coded as they were. If that's the case, it's still 'real' money (i.e., instead of receiving cash, he received stock).

    Here's the applicable footnote for the 'purchase:'
    Explanation of Responses:
    ( 1) Shares were acquired pursuant to a restricted stock grant and generally vest one-third on the first anniversary of the grant, with the remainder vesting quarterly over the remaining two years.

    http://bit.ly/1dQI8v9

    Note this for the last item in the filing:

    ( 6)
    The right to exercise the above stock option is tied to performance-based objectives relating to the timing of patient enrollment and positive data release for the Company's Phase 1/2 HSV-2 clinical trial. Mr. Samant's salary remained unchanged at 2013 levels and he received no cash bonus.

    So, VJ has a lot riding on the outcome of the HSV-2 trial.

    Ted
    Jan 15 08:26 PM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    Yes, they exercised grants and purchased the shares for the full price.

    What surprises me is why they laid out the money. Why not simply award themselves gobs of options at the beginning of the year (valued at $0 or the current price) and keep their money in other instruments...unless it was urgent to start the clock running on long-term capital gains now.

    By the way, it is possible the transactions were miscoded on the forms. Here is VJ's:

    http://bit.ly/1dQI8v9

    The first transaction is coded 'P,' which is for an open market purchase.

    But here is the relevant footnote:

    Explanation of Responses:
    ( 1) Shares were acquired pursuant to a restricted stock grant and generally vest one-third on the first anniversary of the grant, with the remainder vesting quarterly over the remaining two years.

    The remainder of the transactions were for tax purposes, as you say.

    Here are the Form 4 codes:

    http://bit.ly/1ajrSWm

    Perhaps the transaction should have been coded 'A.'

    Ted
    Jan 15 12:04 PM | 1 Like Like |Link to Comment
  • What's Up With Vical? [View article]
    By the way, James Singer still holds 8,670,000 shares.

    Ted
    Jan 15 09:28 AM | 1 Like Like |Link to Comment
  • What's Up With Vical? [View article]
    It's always possible someone has been poking around and doing their DD.

    As an aside, I had expected the dengue fever vaccine trial to read out by now, as well. This is the Phase 1 trial with the US military:

    http://1.usa.gov/1aFQ1qj

    But that's way too early in the pipeline to have a significant impact (though dengue is growing as a threat, to be sure).

    Ted
    Jan 15 09:25 AM | Likes Like |Link to Comment
  • What's Up With Vical? [View article]
    There actually were four insider buys. You can track all insider activity for VICL on this site:

    http://bit.ly/1aFNIDw

    Ted
    Jan 15 09:14 AM | 2 Likes Like |Link to Comment
  • Vical Initiates Trial Of Therapeutic HSV-2 Vaccine [View article]
    Actually, he bought them a few days ago, last Friday, to be exact.

    http://bit.ly/1hocTvL

    By the way, the CAO purchased 70,000 shares and a VP purchased 90,000 shares on the same day. Hmmmmmm

    http://bit.ly/1hUN9tS

    Insiders buy for one reason...they expect to make money. I wonder if someone is 'poking' around, doing DD? It will be interesting to see if the officers begin exercising their options.

    Ted
    Jan 14 05:31 PM | Likes Like |Link to Comment
  • Vical Initiates Trial Of Therapeutic HSV-2 Vaccine [View article]
    Details of Vical's HSV-2 trial on the FDA's Web site:

    http://1.usa.gov/KPrcyy

    Locations

    United States, Oregon
    Westover Heights Clinic Recruiting
    Portland, Oregon, United States, 97210
    Contact: Amanda Atkinson 503-226-6678 amanda@westoverheights...
    Principal Investigator: Terri Warren, ANP, RN

    United States, Texas
    Center for Clinical Studies Recruiting
    Houston, Texas, United States, 77004
    Contact: Jesse Villanueva 713-528-8818 ext 1201 info@ccstexas.com
    Principal Investigator: Steve K. Tyring, MD
    Jan 10 01:45 PM | Likes Like |Link to Comment
  • Vical Initiates Trial Of Therapeutic HSV-2 Vaccine [View article]
    Even Adam joked about the vote re VICL:

    Adam Feuerstein ‏@adamfeuerstein 16 Dec
    I suspect Ken Luskin is playing around w/ my Worst Biotech CEO poll --> http://bit.ly/1gmvZkY

    And then you have the results:

    Who is the Worst Biotech CEO of 2013

    Joe Zakrzewski, Amarin 573 Votes 4%

    Harvey Berger, Ariad Pharmaceuticals 2099 Votes 15%

    Vijay Samant, Vical 10139 Votes 70%

    John Johnson, Dendreon 839 Votes 6%

    Tuan Ha Ngoc, Aveo Oncology 850 Votes 6%

    Total number of people voted: 14440

    http://bit.ly/1gmvYgW

    Even voting in Chicago never got so 'good.'

    As phony as it comes.

    You, of course, are entitled to you opinion. But I think we've taken this discussion to the end of the road. I'm done here.

    Ted
    Jan 9 05:41 PM | Likes Like |Link to Comment
  • Vical Initiates Trial Of Therapeutic HSV-2 Vaccine [View article]
    I suggest you confirm that with the corporation. (BTW, I doubt there is a publically held company out there that does not carry insurance against such lawsuits.)
    Jan 9 03:18 PM | Likes Like |Link to Comment
  • Vical Initiates Trial Of Therapeutic HSV-2 Vaccine [View article]
    Assuming the lawyers are successful in finding a lead plaintiff, and assuming there's an award, probably none...it will be covered by insurance.
    Jan 9 01:57 PM | Likes Like |Link to Comment
  • Vical Initiates Trial Of Therapeutic HSV-2 Vaccine [View article]
    Until details are posted to the FDA Clinical Trials Web site, you know as much as I do...which is what was provided by the company in its press release. One might assume any activity ongoing at this point is related to the qualification of patients to be enlisted in the trial.

    Ted
    Jan 2 10:45 AM | Likes Like |Link to Comment
  • Vical Initiates Trial Of Therapeutic HSV-2 Vaccine [View article]
    The failure of a Phase 3 trial is not unusual, though many certainly expected the outcome of the AV-7 study to be positive.

    That said, in the months prior to Vical's disappointment, there were other notable failures, including, but not limited to:

    1. Eli Lilly's ramucirumab against breast cancer
    GSK) announced today that the first of four Phase III studies, the SHIELD-1 study, investigating vercirnon - an investigational CCR9 antagonist - in adult patients with moderately-to-severely active Crohn’s disease did not achieve the primary endpoint of improvement in clinical response and the key secondary endpoint of clinical remission."

    3. Pfizer's investigational compound inotuzumab ozogamicin
    http://bit.ly/1dPKtZ2

    "Bad news for non-Hodgkin's lymphoma (NHL) sufferers: Pfizer is discontinuing a Phase III randomized, open-label, two-arm study (B1931008) evaluating the investigational compound inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive NHL who are not candidates for intensive high-dose chemotherapy. Apparently, the drug just isn't working as well as they hoped it would in this situation."

    As for the DMSB (sic), they had no window into efficacy...only safety. That was made clear repeatedly throughout the conduct of the trial.

    And for those who rail against both the company and the DSMB because of the deaths in the AV-7 cohort, I am reminded of two trials in 2007 involving prostate cancer drugs:

    1. Novacea's Phase 3 ASCENT-2 clinical trial of Asentar
    http://bit.ly/1dPKtZ5

    "Novacea announced today that the company has ended its Phase 3 ASCENT-2 clinical trial of Asentar(http://bit.ly/sVKgLS) (DN-101), the company's lead investigational cancer therapy for the treatment of patients with androgen-independent prostate cancer, or AIPC, due to an imbalance of deaths between the two treatment arms, as observed by the Data Safety Monitoring Board (DSMB) for the clinical study."

    By the way, recall this was the study on which Dr. Howard I. Scher of Memorial Sloan Kettering was co-lead. Three weeks after the FDA turned down Dendreon's BLA for Provenge (May 8, 2007), Schering Plough signed a $440 million dollar co-development deal with Novacea for Asentar. Scher, of course, was one of two panel members-the other was Dr. Maha Hussain-whose letters to then-FDA Commission von Eschenbach, disparaging Provenge were leaked to and published by The Cancer Letter. These letters figured large in the FDA's rejection of Provenge at the time. I don't recall seeing extensive discussions regarding the imbalance of deaths in the treatment arms in the popular literature.

    2. Cell Genesys terminated VITAL-2, the second of two phase III clinical trials of Gvax immunotherapy for prostate cancer. -
    http://bit.ly/1dPKufj

    "Cell Genesys ended the trial after its independent data monitoring committee observed a high number of deaths among patient (sic) receiving the drug versus those on another treatment regimen."

    Here, too, there was very little made in the popular literature about the high number of deaths among patients receiving the drug.

    You're certainly entitled to your opinion, Robert. But I thought I'd throw in a few facts for you and my readers to consider.

    Best of Seasons.

    Ted
    Dec 18 08:38 PM | Likes Like |Link to Comment
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