This is not a $5 dollar stock..... this is a $35 dollar stock-- pre market one morning.
This press release just verifies what we knew several years ago, that this drug we call Ampion will richly reward us longs..... The FDA who have been very friendly to Ampio in pre trial design, very friendly to us, the FDA will move this along, and over the coming days we'll see their decision in this regard as Ampio did nothing wrong and this is well known! Over the years Ampion has relieved the pain in literally thousands of people with no and I mean no adverse side effects, uh, yea folks we do have a winner here~
Good PR this morning, which makes you wonder why they didn't host a conference call last week to go through some of the issues--mgmt dropped the ball there. I still think the drug is active based on all the clinical evidence so far, so it comes down to the FDA whether they accept AMPE's explanation and salvage plan. Cash could be an issue as they said they have enough for 2015--but if they file BLA in March, and could be some back and forth due to the change in plan -- approval could be delayed in 2016. Also, the company might want to have some cash before going into partnership disucssions so they are not "under the gun" to sign something where the economics is not ideal.
ri66, my hopes are the AMPE will release the subset 25-30% that is unaffected by the temperature which will substantiate SPRING. Based on all trial results so far there will be low risk of this not happening but statistical significance will be affected. Regardless, the MI will then be used with Spring so the BLA will proceed. I work in Regulatory so I can tell you this is a procedural mishap that gives a very rare buying opportunity. Most often it is the drug that fails and results/statistical significance is affected. AMPE however has enough cash to finish MI studies and may show healing. I still think there are big pharmas looking at AMPE and weighing the benefits of purchasing this company right now - it is undervalued. There's growing evidence that HA injections do not benefit patients so there is a frantic search for the next OA standard care. Ampion looks like it will be that treatment with solid science and trial results so far. If MI studies are good it will be breakthrough.