Sold. They are cooked. Massively in debt. Delisting. Cash until Q1 2009....they will need to do additional clinical trial with VV - as per the other vendors - as this is a FDA request in light of the skin problem - NSF issue---see FDA and other companies in this area.........they will not find any other partner to monitize VV as too much at stake....they are cooked
I disagree on Vasovist and the FDA requiring future NSF study on this application..I believe they get an approval w/ a limited label based on the multitude of studies as well as those agreed upon studies(3?) from this past summer.
NSF was well established as a problem w/ other GD products and FDA did not include that as a precondition for approval... so I believe they may ask for POST MARKETTING SURVELLANCE of NSF other side effect issues...to continue and the label will warn about the potential even w/ vasovist but not demand any study to further prove what we have not seen already in thousands of studied patients.
NO NSF reports w/ vasovist! Show me the study done w/ Vasovist where they found NSF! You can not because I have read them all and that does not exist as a problem!
Your other concerns are duly noted but I might add NASDAQ delisting appeal process could take two months and they will stay LISTED!
The $100M Bond could be called upon a failure to lose the Appeal Process but I doubt that is the case. The $3M interest payments are easily made! If the Bond is called they will refinance or recollateralize potentially calling on partners and naming new projects which will receive upfronts. They are OK on cash through Q 1 of 2009. I expect Vasovist approval and EPIX will tell us about the partnership/monetization which could make them healthy quickly.
I expect a BUYOUT prior to any of this by GSK based on GSK wanting to drive the two 3140 studies through completion and paying for the company now. They can get all of EPIX for $150M if they want to push a deal so that is 3.61/share buyout IMO!
Frank are you losing it? I don't follow your post. I ask again. When do you expect VV approval. I suffer PAD and have more than a financial interest in this. Call me a whiner but "are we almost there yet?" lol