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  • AMBS Must Come Clean To Shareholders

    Questions:

    1. Who is the principal investigator for the ongoing LymPro trial. Also, how many LymPro trials are going on.

    2. What/where are the 4 sites that are conducting LymPro trial.

    3. When (exact date) did the trial begin.

    4. When is the enrollment expected to finish. And the analyses.

    5. What is the cohort size, and the break up of Alzheimer's, cognitively healthy, and other dementia patients.

    6. What are the primary and secondary endpoints.

    7. What are the patient inclusion/exclusion criteria for enrollment.

    8. What is the procedural timeline for each patient, from enrollment to final diagnosis.

    9. What specificity/sensitivity numbers does the company will be satisfied with, as regards to making a clinically meaningful impact.

    10. An estimated 5.2 million Americans have Alzheimer's disease in 2014. Claiming statistical significance in a cohort with 10 AD patients, is garbage. Why is the company working with such small datasets? How much money has the company earmarked and spent so far on these LymPro trials.

    11. The CEO mentioned in his blog that LP-002 bridging data could be withheld (from AAIC) and released later (at C4CT). This "withholding" unequivocally means that the company either had peer-reviewed LP-002 data at the time of publishing the blog, or at least get the data peer-reviewed before AAIC. Between July 15-31, it is impossible to buy that the company did not know already that the LymPro bridging study will not be fully enrolled, let alone analyzed, submitted, peer-reviewed (which can take 1-6 months). Not even finishing enrolling before C4CT shows that the management (a) lied in the blog, (b) missed the target twice, at AAIC and then at C4CT and/or (c) the management is spinning a failure. Were the investors deliberately misinformed? If not, please explain the following:

    a. Is bridging enrollment complete.

    b. Is bridging analysis complete.

    c. Has bridging data been submitted for publication.

    d. Has bridging data been peer-reviewed by referees already.

    If readers/investors have any other questions, please add in the comments.

    Tags: AMBS
    Aug 01 6:45 PM | Link | 3 Comments
  • Inovio Management Shares Its Views On VGX-3100 Phase-II Success And More

    1. As a technology proof of concept, we are very pleased to achieve these (VGX-3100 phase-II) results. We just opened many new doors to advance product development and business development opportunities.

    2. We expect efficacy - T cell immune response correlation to be addressed in a published paper.

    3. Chemo/radiation are not HPV specific and they are not used for pre-cancers. The reality is that the dynamics of HPV progression and regression are not well studied and documented. Our work is going to be an important step in advancing that effort. HPV not eliminated by some kind of human intervention may then persist and cause CIN (pre-cancer) or cancer. In some cases the immune system may achieve natural regression. But assistance in that process by a non-surgical approach would be extremely beneficial.

    4. The HPV clearance difference observed between VGX-3100 and placebo groups is very significant.

    5. FDA will comment on whatever we might propose as a next-step clinical study. Contrary to what one writer with a mission has suggested, current procedures are not just a walk in the park. The surgical LEEP procedure is extremely invasive, it does pose some future risk of resulting in pre-term births, and it does not eliminate HPV, which could therefore result in recurrences in the cervix and possible new lesions in other areas of the body (this dynamic is not at all well understood). If you had a slowly progressing pre-cancer or cancer (think HPV caused in the cervix or prostate in men) and had a 50% chance of avoiding a surgical procedure by using a much less invasive procedure, with the option to use surgery later if necessary, which would you choose?

    6. The 50% just speaks to what we have accomplished and announced so far. If we also choose to look at ways to enhance the responses further, and can achieve that, then the argument just becomes stronger.

    7. There are many variables to be considered about what is the ideal approach to move forward. It will become clearer in due course.

    Tags: INO
    Jul 29 12:28 PM | Link | 3 Comments
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