The upside could be a few multiples of the current price. but with the venture capital company able to exercise its warrants at $1.20/sh. to establish 3/4's ownership of the company , and a negative current stockholder's equity, I believe our most optimistic upside from here to be considerably more modest than to make this a "million dollar holding." The downside of course is bankruptcy.
The FDA mid-hearing changed the criteria for approval from comparison of results to radioactive isotope testing, which Imagify based their testing on and demonstrated equivalence or better results, to wanting the tests to have been done as a direct comparison to ultrasound. Since radioactive testing had already shown superior results to ultrasound, Imagify should have been considered superior also. If Acusphere were to pay to reconduct testing versus ultrasound the FDA could reconsider approval. The radioactive isotope testing industry's exercised their influence on the FDA to get approval blocked. The EU may have more concern for the cost and safety benefits of Imagify and grant approval. The FDA may then reconsider a resubmision objectively, with less influence from the radioactive isotope advocates..
First, my post was just a run on sentence of my recollection of the conclusions of the FDA hearings. I am strictly an amateur observer,and I am a long suffering ACUS stockholder who has stuck around because of the slight glimmer of hope that still exists. You sound like a very disciplined knowledgeable investor. Any purchase of ACUS at this time should only be in an amount your comfortable rolling the dice with.
I would assume that if the venture capital company that holds the warrants to buy at $1.20 had any belief that approval might occur they would be buying every share they could get their hands on below their exercise price. I don't think that SEC purchase disclosure rules apply to a pink sheet stock. I am hoping that's what has been occurring here over the last few months of price movement.
Your last paragraph contains a very signifigant point, MNTA using their characterization process can continually develop FDA approveable generics for patent expiring biologics. AS with their previously marketed product, this will generate a very impressive revenue stream, at least until other generic competition erodes their market share. With MNTA's first generic the FDA approval without requiring a new regimen of testing meant MNTA can expect FDA acceptance of their characterization process to produce equivalent biologics. And unless the courts allow infringement of their characterization patents this should give them market exclusivity or at least a very limited competition. The "Safe Harbor" court ruling may still yet be revised.