I think FDA is accelerating approval for EDAP after EU gave primary recommendation....
EDAP submitted application Feb 2013...but since they got EU primary recommendation on April 24th, looks like FDA is accelarting approval with panel recommendation date given on May 22nd (for July 30th), site visits in June, other reviews in July.
Looks like US FDA was waiting for EU to give their clearance, and how they are moving quickly as they feel much for comfortable.
Expect stock to be at $6 by July 30th, expecting a postive recommendation (they have 15 years of clinical data !! Plus Europe, Canada and Asia are using it already), and FDA approval Aug/Sept latest. Stock will go up to $20 again just like EU approval.
FDA doesn't care what the EU does. The EU has approved many drugs in the past only to be denied by the FDA. The price may get a pop after FDA approval IF IT HAPPENS. However, the stock price will only keep going up if EDAP can prove to investors that they can have sales growth and fund it from earnings instead of continually issuing more shares of stock. If they can't get themselves off of the stock "candy", then the price will go nowhere. Only time will tell.
HAHAHAHA !! You crack me up ! Price 'may' go up if they get FDA approval ! Dude if they get FDA approval stock will go up 200% easy ! When is the last time you saw a biotech/device company not go up after FDA ???
FDA does not care about EU ? Really ?? They why all of a sudden acceleration of reviews/dates since EU recommendation in March ? Check my last post. Check theflyonthewall comments by CEO.
Also EDAP already proved to investors...HIFU revenue up 130% last qtr, profit instead of loss, big backlog, France reimbursement, EU recommendation, which is followed by all of Europe and Asia.
With $20/share, market cap will still be less than 600million dollar! In the meanwhile, there can be possibly more reimbursement approvals in Europe now France has agreed to reimburse and the European board of urologists has recommended the procedure for early stage prostate cancer.
Honestly, current share price is just one joke. Market cap should have been 300m dollars by now.
Also do not forget the company is also exploring other possibilities to treat other types of cancer.