Protocol Deviations And The One Site to Rule Them All – AMPE

Our post last week on Freezergate 14, “Every Picture…” has caused quite a stir. Today Ampion (AMPE)  has issued a “Letter To Shareholders” available here attempting to gloss over some of the Freezergate ’14 issues.

Don’t worry shareholders, these things happen all the time and the FDA is “very positive” as this particularly choice bit suggests:

A discussion with the FDA informing them of the protocol deviation was very positive and the FDA will be evaluating the available data from the trial when presented to them to decide what can be salvaged and how to proceed.

Of course, these things do happen all the time, when you’re AMPE execs Mike Macaluso and Vaughn Clift, MD, who had a previous reverse-merger company, Isolagen, fall apart after “protocol issues”. Isolagen, at one point listed on the affectionately nicknamed scAMEX (now called the NYSE MKT, where Ampio is listed)  later went bankrupt. Read more about Isolagen, here.

And of course this bit brought about a chuckle:

Only one clinical trial site reported any frozen product and that shipment was replaced immediately upon notice.

Only one site. Imagine that!

Finally, are we the only ones particularly impressed at the speed at which the study was enrolled? The company proudly states:

We will not likely repeat the STEP study, even though it took only 39 days to enroll those 500+ patients.

How did they accomplish this? Perhaps through the finest recruiting mechanism available to the discerning physician, also a great source for a slightly used couch, CraigsList.

Just to clear up any site/sites confusion, follow this link to a capture from July 2014 (well before the present controversy) of the Ampio study. Pay particular attention to the following details:

1. Notice that the information was VERIFIED by Ampio in June 2014.

2. Notice that the information was PROVIDED by Ampio.

3. Notice the only listed trial site.

4. Notice the only listed Principal Investigator.

5. Notice the only listed recruiting contact is a woman with a DreamTeamClinic email address.

Draw your own conclusions.

THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.
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