gathering momentum

I have recently spoken to VCR rep (not A.G), who has informed me that there will be a conference call with the FDA to discuss the Unconditional Approval outstanding details just prior to the AGM..... if the FDA doesn't ask for more clarification or questions it may get the nod but no garantees.

He said despite this setbacks and the sluggish start to the BTT (due to ethics committees and lawyers reviewing documents with a fine toothbrush) VCR still believe they can meet all the stated timelines. He believes that recruitment will accelerate dramatically as they get centers up and running.

He said that they will give all more updates on the growing implants and implant centers at the AGM for BTT,DT and Brace and generally the progress in Europe.

He re-iterated that the infrastructure is important. It sometimes takes a while but with all centers operating over the coming 6 - 12 months you'll get a marked increase in implant rate.

All eyes will be on Thoratec's pending approval....in November.....he seemed to state that it was very important annd will have a very very positive impact for all LVAD players.

I asked him about the pooling of data as they had completed about 28 patients for the feasibilty study and he said that they were still trying to get the FDA to approve the pooling of data as they are still in negotiations with them.....this will be VERY important as far as I am concerned because the number of implants goes from 11 to 39 very quickly if allowed. I aksed him to work extra hard on that item.

He also said that American analysts are starting to take notice of VCR as a real competitor to the LVAD market. Commenting on them favourably.


All in all I think as they get through these teething problems 2008 will be a much better year.

Fundamentally a very very strong BUY at these levels for those patient investors....

technically could go either way in the short-term but if it does go down I am postive it won't stay down for long.........i believe a lot of investors and traders are looking for a signal to enter bigtime......hence when the turnaround comes it will be swift and HUGE...