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ImmunoCellular Therapeutics, Ltd. Message Board

daweasl652 70 posts  |  Last Activity: 10 hours ago Member since: Apr 21, 2002
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  • Reply to

    Buy and long, and you won't be wrong

    by cidseldon 11 hours ago
    daweasl652 daweasl652 10 hours ago Flag

    Joe, DO NOT NEGOTIATE with any company until the FDA approves or denies the nda for the generic version of midodrine. We know the trial was completed recently and I'm sure you're aware of the leverage you will have to close an excellent deal for shareholders. - respectfully, the Weasl (lol)

  • Reply to

    Do we know their next earnings report date?

    by mrd171742 Apr 10, 2014 6:33 PM
    daweasl652 daweasl652 Apr 10, 2014 7:28 PM Flag

    our poor little doggie Chtp, abandoned to the pound, nobody (BP) wants to provide a home. ___________________________________________________________

    Chtp put out a p.r. last month, 3/15, with quarterly and year end earnings. No c.c. - I suppose they could do the same this month, Zzzzzzz. - One can only hope Joe has "sources", would be nice if he can get his hands on a copy the midodrine trial results. Wave the failure in front of Biogen execs ? Lol. A partnership or BO will be a completely separate event from the 1st quarter earnings release. I think deal making is over till we see the FDA decision on that NDA for Proamatine. (sic)

  • Reply to

    Investor? Gambler?

    by frankposting Apr 10, 2014 3:37 PM
    daweasl652 daweasl652 Apr 10, 2014 7:15 PM Flag

    loontrader - Your posts, replies + links are appreciated - Thanks. ....the weasl : )

  • daweasl652 by daweasl652 Apr 10, 2014 2:56 PM Flag

    this is the trial the FDA will base decision on. - approve or remove generic midodrine
    ________________________________________________________________

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    Study Record Detail

    Trial record 1 of 1 for: NCT01515865

    Previous Study | Return to List | Next Study

    Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

    This study has been completed.

    Sponsor:

    Shire

    Information provided by (Responsible Party):

    Shire

    ClinicalTrials.gov Identifier:

    NCT01515865

    First received: January 18, 2012

    Last updated: April 7, 2014

    Last verified: April 2014

    History of Changes

    Full Text View
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    No Study Results Posted
    Disclaimer
    How to Read a Study Record

    Purpose

    To study the effect of midodrine against the symptoms of orthostatic hypotension



    Condition

    Intervention

    Phase

    Symptomatic Orthostatic Hypotension
    Drug: Midodrine HCl
    Drug: Placebo
    Phase 4


    Study Type: Interventional
    Study Design: Allocation: Randomized
    Endpoint Classification: Efficacy Study
    Intervention Model: Parallel Assignment
    Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
    Primary Purpose: Treatment
    Official Title: A Phase 4, Randomized-withdrawal, Double-blind, Placebo Controlled, Parallel-group Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic Hypotension


    Resource links provided by NLM:


    MedlinePlus related topics: Fainting Low Blood Pressure

    Drug Information available for: Midodrine hydrochloride
    U.S. FDA Resources


    Further study details as provided by Shire:


    Primary Outcome Measures: •Score on OHSA rating scale [ Time Frame: 30 minutes post-dose on Day 16 ] [ Designated as safety issue: No ]

    •Syncope/Near Syncope within 15 minutes of standing [ Time Frame: 30 minutes post-dose on Day 16 ] [ Designated as safety issue: No ]

    Enrollment: 67
    Study Start Date: May 2012
    Study Completion Date: November 2013

  • Reply to

    Midodrine trial.

    by daweasl652 Apr 8, 2014 6:22 PM
    daweasl652 daweasl652 Apr 9, 2014 12:09 AM Flag

    mark87now, read your post and the lightbulb is on ! Yesterday's update: This study has been completed - ..could this mean the results are in, the FDA review is April ? Speculation, one of my best attributes LOL .Glta, Joe superman, holding out till results amidst all the mockery ; )

  • Reply to

    Big news today at Needham conference

    by paggap2000 Apr 8, 2014 6:10 PM
    daweasl652 daweasl652 Apr 8, 2014 11:04 PM Flag

    agreed. looks like FD might be in play here.

  • daweasl652 by daweasl652 Apr 8, 2014 10:21 PM Flag

    Midodrine Update
    February 8, 2012


    FDA’s Center for Drug Evaluation and Research (CDER) and Shire have come to an agreement for Shire to conduct two additional clinical trials to verify the clinical benefit of the drug ProAmatine (midodrine HCL). While these trials are taking place, CDER’s proposal to withdraw approval of midodrine has been put on hold.

    Should CDER determine that Shire has failed to adhere to the terms and timeframes in the joint agreement, as outlined in a December 2, 2011 letter1 to Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., or that the clinical trial results fail to verify the drug’s clinical benefit, Shire has agreed to have FDA withdraw approval of the New Drug Application for ProAmatine and to waive its opportunity for a hearing.
    ________________________________________________

    if data is a bust, we're going to love our doggie Chtp : )

  • Reply to

    Midodrine trial.

    by daweasl652 Apr 8, 2014 6:22 PM
    daweasl652 daweasl652 Apr 8, 2014 10:00 PM Flag

    -The replies have made this a valid thread. Thanks

    - We have our work cut out for us. "Under no obligation to post results publicly" ...I must be honest, I have done NO dd on the shire drug. Could they have outstanding results ? We must be objective . Do not allow our $$ in Chtp to skew our analysis of the Shire trial. IF we can find it. I estimate 2 months minimum from trial end to data release........ok, forget all that. The FDA will make a decision, I guess. ? Sorry about the babble, the remove feature will be in play tomorrow.

    FDA site, a quick glance of Midodrine history with them.

    fda (dot) gov/........Drug/.........DrugSafe ------ remove the dots -

  • daweasl652 by daweasl652 Apr 8, 2014 6:22 PM Flag

    - This study has been completed - 4/7/14

    NCT01515865 , Shire Pharm.

  • daweasl652 daweasl652 Apr 7, 2014 7:08 PM Flag

    bb44, - I enjoyed your reply. - I'll stand by my "new melanoma trial" ie: new dosage, new timetable - Data used towards ph III design will not incorporate the lower dose result.

    - "trial that is currently producing the best in class data" - Who said this and where can I find it, thanks.

    - "relaunch (are) occurring because their data is that good" - I'm not aware of published data for the T cell Lymphoma trial, you've seen it ? Link.

    The gentleman jbem777......It's nice to see an intelligent, educated investor in Oncs. - "a faster conclusion to the study than originally planned." An excellent explanation justifying the term relaunch. Reading his post, at no time did he say EP/IL must be working. The jump from new parameters in the trial to -showing efficacy- cannot be made. Not yet. end of discussion , lol ! : )

  • daweasl652 daweasl652 Apr 7, 2014 11:45 AM Flag

    lady.domina2 - you are an astute investor and you are correct. The melanoma trial, 9 months after full enrollment Oncs announces "21 new patients to be enrolled at a higher dosage and increased dosing frequency" - It should be obvious to investors, Oncs has not found the MTD, essentially starting a new melanoma trial, the only reason to change dosage is to improve on existing trial results. - The re-launch of T cell lymphoma trial, same thing - .....got to go, back tonight, with examples of failed ph II trials, data mining used to announce "moving on to ph III" .

  • daweasl652 daweasl652 Apr 5, 2014 4:58 PM Flag

    .....sorry to clutter the board with messages .....but my reasons to guess Melanoma - The ph II trial had full enrollment last June per the Oncs p.r. , open label, I believe 25 patients. The data generated by this trial should be near conclusive, something I believe ASCO prefers. We've all seen the DSMC give the green light on safety and efficacy looking at interim trial results, only to see missed primary endpoint (fail) at trial conclusion. The MCC trial, planned enrollment of 15 patients, began in 2011. Three years later still enrolling, well till now. I would prefer an MCC abstract at ASCO. April 21st our speculation will end, if abstract not accepted, I hope Oncs will make available on their site.

  • daweasl652 daweasl652 Apr 5, 2014 4:06 PM Flag

    With all due respect to everyone on Ihub, It's nice to see the CONFIRMATION of my earlier posts.
    ____________________________________________________________
    - Dr. Adil Daud, M.D., oncologist, melanoma specialist- with his expertise in the melanoma field, Dr. Daud's experience puts him in a position of high demand. . . .. . . . . .. . .
    - With respect to his AACR schedule this weekend. Those presentations have no correlation to Oncosec Medical. _______________ 4/4/14, Friday afternoon.

    - Reading the abstract title, looks to be a Merck abstract,..there will be no p.r. from Oncosec ....... no connection whatsoever. ______________ 4/5/14, Sat., 10am
    ______________________________________________________________

    call it an educated guess, lol , the asco abstract submission, melanoma ph II.

  • daweasl652 daweasl652 Apr 5, 2014 9:47 AM Flag

    I guess we'll know more Sun. afternoon. - Reading the abstract title, looks to be a Merck abstract, their anti PD-1 drug, MK-3475. , in a melanoma trial. .....There will be no p.r. from Oncosec Medical - nada, zip, zero, no connection whatsoever. Clinical trials have not begun using Oncs EP/IL-12 and anti PD-1 drugs. Stay tuned. : )

  • daweasl652 daweasl652 Apr 4, 2014 5:37 PM Flag

    craigakess - all those thumbs down, lol, it's your refusal to wear rose colored glasses ! I like your post............keeping it real time and time again. thanks.

  • Reply to

    Daud presenting at AACR this Sunday......

    by twiz0019 Apr 4, 2014 7:30 AM
    daweasl652 daweasl652 Apr 4, 2014 5:25 PM Flag

    jepetersonus, I appreciate it when an investor is willing to do some serious research into an equity they hold. That being said, I hope you're not adverse to an opposing opinion : )

    Dr. Adil Daud, M.D., oncologist, melanoma specialist. - With his expertise in the melanoma field, Dr. Daud's experience puts him in a position of high demand. Lead investigator for the melanoma trial gives the Oncs EP/IL-12 technology an increased 'credibility', for lack of a better word.

    With respect to his AACR schedule this weekend. Those presentations have no correlation to Oncosec Medical. Yes, a partnership with Merck does seem likely especially with the addition of Dr. Pierce, personally I hope Merck is willing to sign on with Oncs by summer, after a thorough review of data/abstracts that should be released in May. The MCC paper.

  • daweasl652 by daweasl652 Apr 3, 2014 12:48 AM Flag

    Who completely understands the post below and can explain the argument for failure.
    _____________________________________________________

    kahn_boonie • 6 hours ago Flag

    ONCS is a sham, or in another word, an imitation. INO's approach is potentially revolutionary, but fraught with risks. INO's choice to deliver plasmids as vaccines has a hell of a lot better probability of success to elicit sufficient immune response. One of the biggest questions is whether electroporation will enable sufficient delivery of these plasmids (i.e. will doses be delivered high enough) in sufficient quantities to elicit adequate T cell response. As I understand it, INO is not delivery milligrams of these plasmids, as that would be prohibitively expensive. Delivering chemotherapeutical agents, which is what ONCS has licensed the electroporation technology to do from INO, will require nanomolar concentrations to be achieved within the target cells. That will be orders of magnitude more "actives" required to be delivered. Which one are you willing to bet on, a manned mission to Mars (INO) or a manned mission to Alpha Centauri (ONCS)? You can certainly bet on both; but which one do you think has a better probability of success? Less
    _____________________________________________________________________
    cribbed from the chtp board.

  • Reply to

    Interesting Observation

    by usingaliase Apr 2, 2014 8:25 PM
    daweasl652 daweasl652 Apr 2, 2014 11:56 PM Flag

    the weasl stuck his nose under the big tent, did a TON of reading too. by hook or by #$%$ shares will be had. with the existing float, Igxt can easily carry a higher price per share. GLTA

  • Reply to

    Regarding ASCO submission

    by brotherbear44 Apr 1, 2014 4:27 PM
    daweasl652 daweasl652 Apr 1, 2014 5:26 PM Flag

    MCC abstract not eligible as late-breaker, randomized trials only.

  • Reply to

    Moving up my timeline

    by borgati4 Mar 29, 2014 9:51 AM
    daweasl652 daweasl652 Mar 29, 2014 12:06 PM Flag

    With the 1st quarter ending , I want an earnings call this month. No more hiding from investors. Put it out there Chtp, answer questions. Typical generic answers are the norm in bioland. They CAN say "we're actively seeking a partner and/or a buy out." They can also say, "initial offers did not meet our expectations" , but I doubt they would actually put that out there. borgati4, your posts are appreciated, thnks.

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