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Ampio Pharmaceuticals, Inc. (AMPE)


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0.7608-0.04 (-5.08%)
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  • Any thoughts as to the possibility that some type of merger is in the works? Many biotechs that are out of cash have to merge, even with private or others in similar situations. We may just wind up with a minor stake in some other concern. Those are almost never at any premium. Shouldn't take this long to raise $12M if there was demand.
  • Almost June and still no word on a conference call.
  • Just received copies of the Ampio class action. Only $3.4M. Hard to imagine that has anything to do with inability to finance, or at least inability to tell investors about financing. If the company gets funded to YE a big weight will be lifted. Just not sure from what level if significant dilution is coming!
  • Bill, I don't see a merger at all that makes zero sense at this point. I am not worried as others on the financing. I think that is a done deal and non significant. The big concern will be does this hit the 58 pct average success in K4 as in previous trials. IF so we cash out if not good bye. See you boys mid oct for results. OUT
  • From my post 2 months ago... Next hurdle isn't guaranteed success. But first, they need funds. Has to happen soon or they won't be able to meet the next payroll. Stock is certainly acting like it's not an issue.
    -----------
    The probable reason that the FDA refused to allow filing with available data is that so few KL4 patients have been treated in any of the trials. So, while a 60% RR is interesting and replication is encouraging, the sampling is inadequate to prove statistical significance. So, they were told (multiple times) to run another trial. PIVOT is the most encouraging since the numbers are the largest. Since they did not include these numbers in the presentation, the best estimates are as follows:

    Trial #KL4 #KL4 given Ampion
    SPRING 74 32
    PIVOT 110 55
    STEP 52 26

    Numbers from SPRING are from PLoSOne paper. STEP from PR releases (non-frozen samples, %KL4 from SPRING distribution), PIVOT calculated from total enrollment and necessity to replicate SPRING. Actual treated KL4s are from PLoSOne or 50% of total. Replicating SPRING RR with 23 more patients is certainly good. STEP is highly suspect. We don't know if they included frozen samples or not in that RR data.

    If 170 are enrolled in the next trial, 146 will receive Ampion. 87 would need to respond to replicate prior studies.

    **That is 32 more patients than PIVOT (60% more). So it is not without risk given how non-uniform OAK is.
  • Most here do not also have an investment in FLXN, but the interview on CNBC today is still worth watching.
    Wish our CEO (or anyone else in management) came from big pharma and spoke as fluently about the field.

    http://video.cnbc.com/gallery/?video=3000621085

    Flexion CEO on developing an alternative to opioids

  • Cingal has now also satisfied FDA requirements for 2 pivotal trials showing benefit beyond saline. Highlights from release:

    * CINGAL reduced WOMAC Pain by 70% at 12 weeks and 72% at 26 weeks as compared to saline - more improvement than that reported in previous viscosupplement studies.2, 3, 4, 5
    CINGAL demonstrated rapid pain relief following administration (a 59% improvement in WOMAC Pain at 1 week and 68% at 3 weeks) - unmatched by prior trials of triamcinolone hexacetonide alone.6, 7
    CINGAL met all primary and secondary endpoints relative to saline in the ITT analysis.
    CINGAL demonstrated significant improvement with respect to most secondary endpoints for pain and function at most time points through 26 weeks.
    At 1 and 3 weeks, CINGAL was significantly better than MONOVISC for most endpoints.
    CINGAL and MONOVISC provided similar benefits from 6 weeks through 26 weeks.
    CINGAL was shown to be safe, and was associated with a low incidence of adverse events (n=6) that resolved over time. There were no serious adverse events considered to be related to CINGAL.
  • Hopefully, any dilution will not drop the stock below last warrant price. Probably a combination with debt, per 10Q statement. Of course "investment partner" could include a pharma partner. That would be big but so far no indication of interest. I still prefer trading deal value should trial work vs upfront cash and the confidence an experienced partner would bring. There's been plenty of time for those discussions to occur post-FDA guidance.

    But, we don't know what the real chance of the trial working is. It *should* be ok, but that's what I thought about Pivot since it was replicating Spring and better controlled. The better-controlled trial failed (and correlation with severity as well: KL2 had better relief 52% than KL3 36%, neither being better than saline). KL4 response and WOMAC pain relief were similar- our best hope. But, samples are small and obviously a wide variety of patient responses. If they pre-screen for macrophage biomarkers or something similar (claimed by Bar Or as the MOA in vitro, but large p=0.05) that could help.

    Should know soon. Maybe even a relief rally if dilution is minimal and trial fully funded.
  • $AMPE is today the day MM finally announces the financing aspect which keeps the lights on for another year?? Stock acted like news was forthcoming yesterday.

    A lot of late action as price closed at the HOD!!

    Follow thru on price will bring the MOMO TRADERS back into the stock and reclaim a dollar or more. Secure finance or a partner should bring a price move back to the 2-3$$ range quickly
  • Tufts did a study of Triamcinolone and found the below results. As a side, I also pasted this excerpt from Flexion's website so you know how the Tufts study relates to Zilretta... Perhaps Sanofi figured out the same thing as Tufts?

    ZILRETTA TM (FX006)
    An Intra-articular, Extended-release Formulation of Triamcinolone Acetonide under Investigation for the Treatment of Osteoarthritis of the Knee

    http://jamanetwork.com/journals/jama/fullarticle/2626573

    Summary-
    The decrease in knee pain did not significantly differ across treatment groups: −1.2 units in the triamcinolone
    vs −1.9 in the saline group; between-group mean difference, −0.64; 95% CI, −1.6 to 0.29). Also, there were no significant
    differences in any of the secondary patient-reported or objective clinical end points (Figure 2 and Table 3). Both
    groups exhibited a nonsignificant increase in high-sensitivity C-reactive protein (0.2 vs 0.1 mg/L; between-group mean
    difference, −0.1 mg/L; 95% CI, −0.4 to 0.2 mg/L). At the final visit, 45% of participants guessed their treatment assignment
    correctly.

    Comparison of Intra-articular Triamcinolone vs Saline for Knee Osteoarthritis
    This randomized trial compares the effects of intra-articular triamcinolone vs saline injected every 3 months for 2 years on changes in cartilage volume and pain in older adult patients with knee osteoarthritis.
    jamanetwork.com
  • Today, 5/15/2017 A publication in the prestigious medical journal JAMA written by Timothy E. McAlindon, DM, MHP; Michael P. LaValley,PhD; William F. Harvey, MD; Lori Lyn Price, MS; Jeffrey B. Driban, PhD; Ming Zhang, PhD; Robert J. Ward, MD/ This was sponsored by Tufts University/ reports on a 2 year saline placebo controlled study of 140 patients with osteoarthritis of the knee using intra articular injections of triamcinolone (the same steroid that Flexion (FLXN) is using in their drug Zilreta)! The study authors conclude; "Among patients with symptomatic knee OA, 2 years of intra articular triamcinolone compared with intra articular saline resulted in significantly greater cartilage volume LOSS and NO significant difference in knee pain. These findings DO NOT support this treatment for patients with symptomatic knee osteoarthritis. From my findings, Ampio Pharmaceutical's Ampion drug is the only remaining drug for this condition and hopefully will be approved by the FDA!
  • Still no trial registration. Seems that was probably just a PR attempt. We should get a "real" PR when they announce first patient recruited. But, money has now run out per 10Q so we wait to hear what the next desperation financing move is (EQUITY & DEBT). Perhaps a CC after that.

    10Q:
    "Note 2—Going Concern ...
    The Company expects that its current cash resources as well as expected lack of operating cash flows will not be sufficient to sustain operations for a period greater than a few weeks from this Form 10-Q issuance date. The ability of the Company to continue its operations is dependent on management's plans, which include continuing to raise equity-based and debt financing. The Company is currently in negotiation with potential investors for financing. There is no assurance that the Company will be successful in raising sufficient capital."
  • AMPE up 5 cents, how much sleep will "BIll The Fraud" lose this weekend???
    I'm sure he'll find some negative fake news in order to make his weekly quota.
    I'm hoping that money flows into Ampio regardless of the structure. Being realistic, it is the trial that will count as a winner or loser! I say, I can lose 79 cents or make $10! In April, I said I can lose 57 cents or make $10!
  • Bill, there is a movie from 1970 called "Kelly's Heroes", in is a character named Moriarity. of which you remind me of. Donald Sutherland's character "Odd Ball", always says to Moriarity, "always with the negative waves Moriarity, always with the negative waves."
  • No need for concern, BIll The Fraud will invest!,
    How pathetic is it that a short selling fictional writer
    Is writing as if he owns shares! BTF doesn't even have his rent money!
  • BTF/ Bill,
    You must have inside information to make such statements!!
    You are the biggest (BIll The Fraud) pile of none sense I've ever seen.
  • BIll The Fraud is not only a Fraud, he's a Fraudulent idiot!
  • Wonder if the Company will even bother to have a conference call???????????
  • "Bill the fraud" did not respond to my post with answers! All he did was was indicate that the JAMA article is fake news!
  • BTF disappears!