Good response. FDA approval is more likely to come Q4 this year....

Good response.

FDA approval is more likely to come Q4 this year. There are a few unknowns with respect to sintering on the pumps but nevertheless it will be sooner rather than later. The FDA approved a pump by Berlin Heart last month that didn't have the rigorous testing that Heartware has done. It should be noted that the pumps aren't direct competitors.

Investors are skittish. Short-sellers in the US are having a field day trading this stock. See Nasdaq.com for short interest movements. Shorters know that the stock is 85% held by institutions holding for the long term so they're just trading the volatility.

100% re-rating. Well it's a strong possibility but I don't think it will come on FDA approval alone. 50-60% seems more likely. But maybe I'm wrong too. Heartware is they get approval this year can really start the ramp up of the MVAD which starts human trials Q1 2012. That's huge news. For my worth the DT trial is neither here nor there as doctors can very easily say they want a HTWR pump for a BTT and just leave it there indefinitely (making it DT equivalent). For this it's critical BTT approval comes sooner rather than later.

The market for heart pumps at this stage is really for Heartware to loose. Let's not forget that Thoratec make a buy out attempt on HTWR because they had given up on their Heartmate III (originally started in 04 or so). Now they have tried to revamp the project to compete with Heartware's LVAD, despite Heartware moving onto the MVAD. Ultimately, Thoratec has dropped the ball.

Finally the LVAD market is extremely lucrative with Gross Profits >70% making Heartware the target for a takeover upon FDA approval.