....the failed STEP trial story tends to strain the imagination that they didn't know about the temp issue until the end. Shouldn't the fact that one of the clinical sites had to have frozen drug replaced set off alarms? And then the PR blitz leading up to the failed trial announcement looks fishy.
Optina data will be out soon, and I assume the FDA would make them run another trial. Ampion open label MI data out in October, and that could move the stock higher if all 7 continue to show huge improvement at week 12. Until then, this still works its way lower. Does it hold $3.00?
Then there is the risk of more dilution next year. I think Ampion clearly works for KL-4 patients, so it is worth something to large Pharma. The problem is whether this (mis)management team can get it there.
The MI trial will be considered a Phase 3, and they'll get an expanded label for multiple injections, which should greatly expand potential future revenue for Ampion once approved.
.....don't feel that way, but people are voting with their shares. The ill advised selective release of the failed STEP trial results is just killing the company.
.....obviously the Market doesn't buy the freeze story. The selective release of STEP results also adds questions. I think drug works, but is only truly effective with multiple injections. The MI 12 week open label results are critical, even though it is only 7 patients. The Market also doesn't believe the MI trial will be considered sufficient by the FDA for a BLA. This will go to $3.00 or lower until there is more certainty.
There is still reason to wonder why they didn't release all the data from the failed STEP trial. Are they hiding something? That being said, I think MI results could be a home run. In the mean time we will go lower yet....this could get to $3.00 or lower without any positive news in the interim. And the bigger question is any news on FDA guidance as to whether MI will be accepted as pivotal. I think they are fighting for their lives right now.
This is incredible. There has been massive selling since the trial fault was reported. I believe AMPE has lost most of their institutional holders, and there weren't that many to start with. I'm thinking this could get to $3.00, which in itself is unreal. There needs to be a PR by the company regarding whether there is any FDA guidance going forward with Ampion. Other than that, the 12 week open label results & MRI's will be critical to the stock price. I'm assuming the FDA will tell AMPE they need to conduct another trial re. Optina. Macaluso unfortunately is a problem, as institutions are wary of him. If Ampion MI trial is a success, this will prove to be one of the great bargains. Otherwise it could be just anther busted Biotech.
The 12 week data from the MI open label will be critical to the stock price - if the "Ampion 7" continue to show exceptional pain relief & function, then AMPE is truly on to something.
So then there it is, AMPE needs to issue some sort of PR stating MI trial design will meet with FDA guidance. Anything less makes the stock uninvest able. My cost basis was $4.00, but I bailed out on everything in the past week. If they need to redo STEP, all bets are off and I wouldn't touch it. If we get a PR that MI trial design will satisfy the FDA, then I think its time to get back in, as MI trial could be a home run. The 7 patients in the open label trial gives some insight into the chances of the MI trial. I believe in the science, which hopefully can overcome the inexperience of management.
....AMPE has stated they believe this will happen, but this is meaningless until FDA accepts it. If FDA agrees, I believe company is back on track after STEP disaster, because I think MI trial could be a home run, and has a much greater chance of success than the aborted STEP did. If FDA requires them to repeat STEP, then the stock will go lower yet. AMPE needs to clarify this ASAP, as their credibility is pretty shot.
....he's going to do The Perp Walk.
The worst part is their bogus PR talks as if the FDA accepting this is a done deal. And there is no way they file a BLA by the end of the 1st Quarter, yet Isolagen Macaluso keeps affirming it.
All that matters now is FDA statement accepting MI as a pivotal trial. If they accept it, the 12 week open label update will give a sneak peak as to what potentially the MI trial could be.