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Ampio Pharmaceuticals, Inc. Message Board

gpost511 14 posts  |  Last Activity: Jun 25, 2014 10:53 PM Member since: Sep 6, 2002
  • Reply to

    DUE DILIGENCE on What ONCS Has to Offer:

    by penny.dung Jun 25, 2014 5:52 PM
    gpost511 gpost511 Jun 25, 2014 10:53 PM Flag

    You are resigned to bankruptcy and 1 in a 100 odds?
    My neighbor is doing some experiments in his basement - wanna invest $25K with him?

  • Reply to

    Abstral 2 Months into Q2

    by lateshownegma Jun 6, 2014 7:39 AM
    gpost511 gpost511 Jun 6, 2014 9:52 PM Flag

    1. Isn't the total fentanyl market $400M in the US? 5% would be $20M.
    2. I would take anything that Ahn says with a grain of salt.
    3.. Let's assume that Abstral does $14M in 2014. That would be about $8M in the second half. Abstral quarterly expenses for manufacturing, marketing, sales ,,,, are $5M to $6M quarterly. So how will it be profitable? Isn't GALE required to run a post approval trial too?
    Don't you have to allocate some of the overhead and management compensation to Abstral? Is Ahn just subtracting the cost of goods sold to project profitability?

    GALE's fundamentals are shaky. It's an open question if GALE will be able to recoup its $30M outlay for Abstral before the patent expires in 2019.
    It's hard to be confident about the Neuvax trial since the patients are a subgroup from a failed trial.
    Why place your bet on a company run by management that can't be trusted. Even if the market cap were $60M, I would have reservations, but $300M?
    There are no other biotechs? I can probably come up with a dozen that have comparable market caps or even a lot lower, with late stage drugs or approved drugs.
    What's the infatuation with GALE. Management screwed shareholders, why hang around and support and defend them?
    Find a little self respect.

    You can't defend the insider sales. I have never before seen insiders en masse dump nearly all their holdings. If that's not a red flag, then what is? But all you have to do is look at the pps now.
    What re-entry? They haven't bought back any shares. The re-entry by awarding themselves millions more free options and then selling the shares again?
    They will get a double benefit. By knocking the pps down they were able to award themselves lower priced options while shareholders took huge losses.
    (the $5 drop in the pps means that shareholders took a hit of over $500M)

    You are raving about the puny Abstral sales that are generating losses. Sure, when you start at zero, the quarterly sales will show increases.

  • FDA resubmission; the latter part of June.

  • I prefer using comparables, as in real estate, to determine valuations.
    The closest comparable to GTHP is EXAS.
    They too are waiting for FDA approval. This is their first go around with
    the FDA, so chances are they will receive a CRL.
    EXAS has inferior "pooper scooper" technology, a diagnostic test for colorectal cancer.
    You know, scoop some poop, mail it to a lab and wait for the results.
    EXAS has a market cap of $1 billion.

  • A renowned medical practitioner Bayo Windapo of the Polybond medical services has said that cervical cancer is curable if it is detected early.

    The doctor made this known at the 2014 Health intervention programme held in Lagos by Human development Initiatives (HDI), a not-for-profit, non-governmental organization working to safeguard the reproductive rights and health of women (particularly widows), children, adolescents and youths.

    Dr Windapo who spoke extensively on cervical cancer introduced a new technology in cancer detection called Luviva. Luviva is designed as a new non-invasive test that has the potential to significantly improve the early detection of cervical precancers. LuViva is designed as a fast, painless test that - unlike Pap smears and HPV testing - does not require a tissue sample or the delay of laboratory analysis.

    "Early detection of cancer and precancers greatly improves survival, and LuViva is designed to help preserve the reproductive health of women" Windapo said.

    LuViva uses proprietary technology to identify cancers and precancers quickly by analyzing light reflected from the cervix. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level.

    Other highlights of the events include; Health screening (Blood Pressure Check, Temperature, Urine test 'Urinalysis', Height and Weight check), Diabetes test, HIV test, consultation and counselling, treatment of minor ailments with available Over The Counter (OTC) Drugs and referral of cases for expert management as necessary.

    (continued)

  • gpost511 gpost511 May 19, 2014 5:16 PM Flag

    Here's what you need know:

    Abstral is generating losses.
    Neuvax will fail as all cherry picked trials fail.
    Combo trials rarely succeed.
    Preclinicals aren't worth mentioning.

    All that you have is hype.
    How much is hype worth?

  • gpost511 gpost511 May 15, 2014 7:53 PM Flag

    I checked the FDA website. Here is the answer: the FDA has 45 days to review the filing to determine if it is complete. When that review is finalized and the filing is acceptable, the PMA is considered filed on the date that the review is completed and the 180 day period starts tolling then. So the 180 days period is firm but the reason that the decision is made after 180 days from the date that the filing is submitted to the FDA is because the PMA is not considered filed until the FDA completes the - up to 45 days review. So in essence, the FDA has up to 225 days to make a decision if the full 45 days are taken to determine the acceptability of the filing.

    "The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.

    FDA will refuse to file the application for substantive review if a PMA application does not meet a minimum threshold of acceptability. If the information or data are presented unclearly or incompletely or are not capable of withstanding rigorous scientific review, FDA may consider the PMA incomplete and not file it. If FDA refuses to file a PMA, FDA will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in the application that prevent filing and will include the PMA reference number. FDA will advise the manufacturer of what information must be provided, or steps to be taken, to make the application fileable."

  • gpost511 gpost511 May 15, 2014 5:51 PM Flag

    45 days from today gets us to June 30th and then 180 days is 6 months, so that is by Dec 31.
    How do you get, possibly early 2015?
    Is it 180 calendar days or 180 business days?
    Didn't GC say within 45 days, so that would mean less than 45 days and the FDA response would most likely come in early to mid December?

  • Reply to

    Short Sale at the Close 93.9K @ $2.16

    by puntacanaphill May 9, 2014 4:12 PM
    gpost511 gpost511 May 9, 2014 4:57 PM Flag

    Most definitely a short sale.
    Monday will confirm it with a gap down opening.

  • gpost511 gpost511 May 9, 2014 4:56 PM Flag

    Hell hath no fury like a woman scorned.

  • Reply to

    It's Quite Simple

    by setto.plunge May 9, 2014 9:50 AM
    gpost511 gpost511 May 9, 2014 4:53 PM Flag

    Can you make them stop?

  • Reply to

    It's Quite Simple

    by setto.plunge May 9, 2014 9:50 AM
    gpost511 gpost511 May 9, 2014 4:51 PM Flag

    Those Ukrainians have it in for us. What did we ever do to them? The stock is down again!

  • Reply to

    There is no "in between" here..

    by puntacanaphill May 9, 2014 4:42 PM
    gpost511 gpost511 May 9, 2014 4:48 PM Flag

    EXCELLENT post. ...... I couldn't have said it better myself.

AMPE
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