"It's important to note that I believe the company has known that the Multiple Injections were the blowout treatment but the FDA wanted the single injection Step Study done first."
Why is what you BELIEVE important?
"The results from the MI study are so overwhelming that there is no question in my mind that the FDA is going to allow that data from the current study underway for the BLA filing."
There are results from the MI study? Those are more important than what You Believe, where can they be found?
"Even though the initial data was for a small number of 7 patients, the data was so extreme that I am confident it will repeat with larger patient numbers."
From the study-
Phase I will analyze safety and, as the study will be open label, no placebo will be used. All patients will receive a 4ml dose of Ampion™ (N=7).
Phase II will evaluate efficacy, cartilage formation as well as safety and the patients will be randomized 1:1, Ampion™ vs. Saline. This second phase will begin after the Phase I safety data is analyzed. (N=30).
Hallelujah, all 7 patients survived. To be "extreme" you must have been expecting the other result.
"Coupled with the fact that the company experienced very serious consequences from the most minor and unexpected procedures, I believe the company is much stronger today to never repeat those kind of mistakes."
Without the, ahem, "unexpected procedures" to hide behind the company would have suffered even more serious consequences. What makes you think that learning to hide bad data isn't a lesson they had already learned?
"Why reward a guy who is overseeing the continued production of defective sensors?"
Knows where the bodies are buried and wants a piece of the options action?
I had a friend who once stated "If you can't tell the same lie twice and with more conviction the second time you have no business telling the first lie."
Apparently a maxim also known to UNXL's management.
More than likely Dell was given the same numbers and did not do an onsite inspection.
The bankruptcy is not over until the Court says it's over.
(9/25/14 is the date for JPMC to present its accounting of what it took during the bankruptcy, assets and liabilities, to the FDIC. Settlement of any issues which arise will take additional time.
As long as there are funds moving into the Liquidation Trust which haven't been distributed the LT will remain open.
None of the above involves WMIH.
"they would guide on how to proceed (even if its to say repeat STEP) and whatever the FDA says would be material and should be released."
The company has already posted that another STEP trial is highly unlikely. If FDA says the current data is unacceptable then MI, a SPAless DMCless, P2,is meaningless.
The longer AMPE can project hope the longer they can keep their charade of being a real company going.
"FDA will be evaluating the available data from the trial when presented to them to decide what can be salvaged and how to proceed "
Given the relatively short time period to the end of the MI trial I expect FDA will not write a blank check for AMPE but will follow the above protocol. Having STEP and MI side by side will be more determinant than a request from the sponsor.
"Expect announcement today see you back at 6.00!!!!!"
Has the MI trial finished,already?
No decision from FDA until the complete data have been presented.
Without a DMC for the trial the odds do not favor an acceptance.
"Further, it is my belief that t his was the companys intent all along."
That is a genius level deduction, no doubt about it.
From Aug 25 letter.
"9. Does Ampio have enough money to maintain operations through this year and all of next year while completing the planned clinical trials and filing for regulatory approval for the two lead drugs?
Yes, as long as we do not directly commercialize either of our two lead drugs, AmpionTM or OptinaTM, which is not our intention."
The same genius suggests-
"To better understand I would suggest that someone take the time to contact FOI services in Rockville to obtain Policy Guidelines or other legislation governing the BLA process for this drug/category."
when a computer search of 'FDA guidance for BLA' will bring all of that information to a screen directly in front of you.
billwilliams admires jts credibility?
While we disagree on the management's focus ( you think they're focusing on achieving production. I think they're focusing on staying out of jail) there are two areas in which we hold common views.
1) Desperate longs see every EVERY little shift away from the day to day monotony as a herald of the second coming( Gateway obviously signifies the threshold of major changes, Palace is the direction those changes will lead. Silence is Golden.But wait there is NO news of a disruptive revolution. This means UNXL has been betrayed and is being held even as we speak by Capitalist forces. Woe! Woe! all about me is ruins!) when this conference was a lesser meet and greet hosted by a third tier publicity firm.
2)Neither of us want jt's halfway house in our neighborhood.
Sources say the Lancaster Pa. chapter for New Unwanted Thought Survivors is planning to expand to Texas.
I'm safe, nobody has ever proposed a halfway trailer home.
"So then there it is, AMPE needs to issue some sort of PR stating MI trial design will meet with FDA guidance."
AMPE cannot issue such a PR.
The FDA will need the post analysis data in hand before they can make a decision whether the data be can used as pivotal.
The trial design must conform to FDA guidance to be designated as pivotal.
The MI trial, NCT02184156, expanded their age criteria last month, before the STEP debacle was made public in a possible effort toward spurring rapid enrollment, from 45 - 55 years of age to 40 - 85 years of age. That is not a show stopper.
Can't say the same for the following combination.
The trial has NO Data Monitor Committee.
The trial criteria description makes no mention of using Intent To Treat analysis .
"a drug that will get approved, but not until yet another trial is run! "
From the company-
"We will not likely repeat the STEP study, even though it took only 39 days to enroll those 500+ patients."
The SPRING trial was not granted pivotal status until after the trial was completed.
If the same holds for the MI study the shareholders can look for 20 or more weeks of uncertainty and a BLA submission if at all with no P3 supporting data.
How is that working out so far? Down 7% or so,right?
It is amazing how little stimulus it takes for people's hopes to be be skewed toward fantastic rewards.
I had Sep. Calls and settled out 80% of them when the premium doubled. It looks like the remaining 20% are going to eat into my profit.
"Go hide under a rock
Go hide under a rock
Go hide under a rock
Go hide under a rock"
You apparently have nothing to contribute.
From clinical curiosity do you suffer from
Echolalia or just a sever stutter?
"Not sure what your background is, clearly not scientific nor do you understand the regulatory landscape of the industry."
A pivotal trial can refer to a clinical trial or study intended to provide evidence for a drug marketing approval, eg by the US FDA. Phase III trials are assumed to be pivotal so the phrase is often used for the rare pivotal phase II trials.
Not sure what your ability to read or comprehend English is. Nowhere in the PR you posted is Phase III mentioned.
Would an attempt to mislead contribute or detract from a proposition that Ampio is attempting to perpetrate a scam? Is it your belief that Macalusa would never mislead you personally?
Per mandatory industry filing study AP-003-A was a Phase II trial.
Clinical Study Protocol: AP-003-A Version 2.0 15May2013
CONFIDENTIAL Page 3
Sponsor:Ampio Pharmaceuticals, Inc.
Developmental Phase:Phase 2
Title of Study:
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and
Safety of a Two Doses of Intra-Articular Injection of Ampion™ in Adults with Pain Due to
Osteoarthritis of the Knee
Approximately 10 sites
Matthew J. Phillips, MD and Brian McGrath, MD
Pain of osteoarthritis (OA) of the knee
Number of patients:
320 total, 80 per study arm: 4mL Ampion™, 4mL placebo, 10mL Ampion™, 10mL placebo
The primary trial objective is to evaluate the greater efficacy of 10 mL Ampion™ versus
10 mL placebo than 4 mL Ampion™ versus 4 mL placebo intra-articular (IA) injection in
improving knee pain, when applied to patients suffering from OA of the knee.
The secondary trial objectives include: evaluation of the safety of an intra-articular injection
of Ampion™ when applied to patients suffering from OA of the knee, evaluation of the
efficacy of intra-articular injection of Ampion™ and placebo on stiffness and function when
applied to ...
" I'm also on the lookout for the knife while you are patting me on the back. "
That is overly dramatic. The worst I can do is post facts.
You are fully capable of imploding without my help.
"So, the drug works conclusively in one Phase III."
There has only been one P3 trial.
Spring was not a P3 trial.
STEP was and it failed.
The MI study is set up to be a P1/P2 trial. It is unclear whether AMPE management has even requested a change.
" Looking at the stock price without distraction is exactly what I'm doing."
Whatever it takes to protect your already fragile self image.
Totally understandable after your other investment debacle.
You obviously have NOT considered the most reasonable explanation for the share price plummeting.
In order to begin wrestling with reality you will have to allow that the impossible has occurred and you have permitted yourself to be made a fool,again.The egos of weak persons are at higher risk of being shattered.It is a positive attribute that recognize yourself as one of those at risk.
You will eventually have to face reality. In the meantime if buying into falling share prices creates in you a perverse sense of satisfaction by all means spend every penny that can scrape up on AMPE shares.
In between your buying sprees perhaps you can develop and share your reasons for believing that AMPE has ANYTHING of substance or value?
Really? You're lying in the face of the headlines.
"Keryx Biopharmaceuticals Receives FDA Approval of Ferric Citrate, a New, Oral Iron-Based Treatment for Dialysis Patients With Hyperphosphatemia"
Your sole purpose here has been masochistically motivated, hasn't it?
You want strangers to despise you as much as you despise yourself.
" I still like my lower support levels"
When AMPE goes into bankruptcy other longs will erect a statue in recognition of your genius.
"regardless of rog, the pps is again getting hammered..."
Thanks hubby, you're right -I have nothing to do with the pps.
Some are totally bewildered by the obvious. Being able to look at it without distraction is a rare talent.