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Ampio Pharmaceuticals, Inc. Message Board

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  • Reply to

    Ampion vs. Shorty

    by wrf1232001 Jun 8, 2015 2:35 PM

    "From Dr Bar Or's recently published scientific paper - "We think that the findings presented
    in this investigation, however, demonstrate that LMWF5A can..."

    Looks like LMWF5A didn't work out as hoped for- no growth apparent. Do you think that Bar Or et al did experiments pre trials or chose to not do so in order to hype the possibility without being liable for, ahem, misdirection?

  • Reply to

    Ampion vs. Shorty

    by wrf1232001 Jun 8, 2015 2:35 PM

    From Dr Bar Or's recently published scientific paper - "We think that the findings presented
    in this investigation, however, demonstrate that LMWF5A can
    alter stem cells function and that the proteomic changes in
    the synovial fluid of patients receiving treatment indicate that
    these observations translate, in part, in vivo. Consequently,
    LMWF5A could prove to be a viable alternative to the existing
    strategies for the treatment of OA of the knee"

  • Reply to

    Ampion vs. Shorty

    by wrf1232001 Jun 8, 2015 2:35 PM

    Probably pointless, but most rational investors here know that there is no evidence of SC generation in vivo and furthermore, many SC therapies as well as OAK pain therapies are in process for end-stage patients as duly referenced in past posts.

    Furthermore, Ampion is a T-cell based mechanism of action, as published by Bar Or several times.

    As stated before, older HA compounds have been approved with similar efficacy issues, but Ampion clearly has not yet met the previous FDA guidance of proven efficacy with 2 "well controlled" and adequate trials.

  • The last news release on AMPION did reach an end point. Do you really believe that the FDA will not approve the filing of the BLA? It is given that Shorty wants you to sell your shares. As the shares drop in price who do you think is buying them? Shorty wants you to believe that AMPION does not work. FACT: No other drug company is working on trials for KL-4 Patients, Why, No drugs work, THIS BIOLOGIC WORKS. It generates stem cells so the body can rehabilitate it's self, read the last news release. They reached an end point.

    The FDA will tell AMPE to file. Big pharma will have to cut a deal and "Shorty" will get fried. Of particular importance is the fact that well informed shareholder(s) believe that the FDA will prefer a filing on both drugs.

    Optina data is great, it did reach an end point. More work will need to be done and big pharma will want to be involved for that next stage.

    If you really want to believe Bill Williams, a know short mouth piece, you can give up; or read/trust the real news; not his #$%$.

    Sentiment: Strong Buy

  • Reply to

    FDA

    by allenstrode Jun 4, 2015 11:49 PM

    Rolling BLA makes this a potential acquisition candidate quite quickly...

  • Reply to

    Hello Bill would you mind commenting on this

    by studman637 Jun 6, 2015 10:27 PM

    You are asking him to comment on your BS post within which you let your total ignorance shine through? Go away..

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    http://stemcellstm.alphamedpress.org/

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    no it's something NEW released a couple days ago in a medical journal - look further in the stem cell journal I mentioned.

  • Reply to

    Hello Bill would you mind commenting on this

    by studman637 Jun 6, 2015 10:27 PM

    Yes, the fact that 2 independent samples were done in MI is also significant. The effects were slightly over 40% of SI, and given innate variation in the disease and scoring, that's likely to be real. We don't have the numbers to independently run the statistics though.

    STRUT was only single site, so less variation in procedure would be expected. I've already noted that the statistics were weaker than what would be needed for immediate approval of sufficient data. The original FDA guidance was for 2 smaller trials rather than 1 larger one so they fully understand the consequences of that guidance on cohort analyses. The 20 wk SPRING KL3+KL4 was p=0.005 vs saline (-0.99 vs -0.65).

  • Reply to

    Hello Bill would you mind commenting on this

    by studman637 Jun 6, 2015 10:27 PM

    SI KL3 from spring was 73 Ampion and 66 Saline with p=0.04.

    The KL3 from both SI and MI is what is impressive, but alone they are less interesting to look at.

  • "MI for KL3 is good".........Really......lets see.....N=59 for KL3s in Stride.....you think we can make that conclusion? Oh I know.....there were was a huge population of KL3 in Strut, I believe it was 12....so between the 2 studies.....we have a winner MI in KL3s......Really? You continue to reach. So......lets parse the data for KL3s from Stride......doesn't matter if the study failed to meet the primary endpoint.........run another study for MI KL3s.......combine the two and submit......wait a minute.....we can throw in the huge database from Strut on KL3 too......There you go.......no doubt FDA will approve that.... Very naïve. Less

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    If it refers to the news articles concerning Kimber's lab showing eSC full cartilage regeneration at 12wks, yes I am aware of it. Still experimental, but one of the best controlled experiments yet. That was in March, but similar studies at the clinical level are ongoing. SC for OA is clearly the future, probably within 3 yrs, but which companies will dominate is less clear.

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    Sounds like they're moving forward with FDA approval process. You don't think they can get it, even for k3?

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    I'm not set up w/ various emails. Pls google "stem cell translational medicine", there is a new white paper, more to come.

  • Reply to

    FDA

    by allenstrode Jun 4, 2015 11:49 PM

    FDA required them to use saline as the "placebo" they actually wanted to use a competitive drug or something else.

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    ..so well said. Unfortunately I learned a hard lesson investing in a highly speculative Biotech with a bogus management team with zero credible background or experience.

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    "MI for KL3 is good".........Really......lets see.....N=59 for KL3s in Stride.....you think we can make that conclusion? Oh I know.....there were was a huge population of KL3 in Strut, I believe it was 12....so between the 2 studies.....we have a winner MI in KL3s......Really? You continue to reach. So......lets parse the data for KL3s from Stride......doesn't matter if the study failed to meet the primary endpoint.........run another study for MI KL3s.......combine the two and submit......wait a minute.....we can throw in the huge database from Strut on KL3 too......There you go.......no doubt FDA will approve that.... Very naïve.

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    yahoo handle works. thanks.

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    Couple things you can count on. Bookmark the post. In a couple of months it will become your new reality when FDA speaks.

    1) Another study or studies will need to be executed.
    2) There will be no form of expedited review. No basis and would have been granted by now.
    3) No partner will surface. The data to date supports minimal value accompanied with efficacy questions.
    4) The current team will attempt to design future studies. Frightening thought. They are 1 for 3 to date.

    Your "analysis" makes far reaching conclusions. While cohort analysis is standard. Selective cohort analysis with insignificant power is not scientifically compelling. I believe it is called data mining. Trust me FDA will not be compelled by SELECTIVE cohort analysis with minimal power. Nor will they be compelled by pooling data from 3 trials (Spring, Strut and Stride). I am sure FDA will also factor in the team is 1 for 3 in pivatol Phase III trials. The best to hope for is Ampio conducts thorough analysis of the data and casts an achievable, pragmatic clinical plan moving forward. The clinical development to date has been a case study in development on the cheap conducted by a grossly inexperienced management team. Extremely risky combination.

  • Reply to

    Bill?

    by ozarkian_33 Jun 4, 2015 8:30 AM

    And your analytical rationale is...?

    It's fine to be skeptical, even short, but try to support your arguments with more supportive data and in depth analysis than adam feurstien.

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