Hi Eire2011, I would like to bring up the discussions between potential takeover bids or go it alone with a partner.
Timeline wise, we should expect to commence Investigational Device Exemption (IDE) first in human TAVR trial around Q2-Q3 pending favourable anti-calcification and sheep’s testing results and also FDA pre-submission feedback. Pre-market approval should happen with further 12 to 24 months before we can sell it on the US market. CE Mark could come sooner I reckon. Btw, don’t think Breakthrough Device program is relevant as there are existing approved devices on the market.
From the company’s announcement so far, looks like the current plan is to sign a partnership deal sometime around Q2/3 for the FIH TAVR trial. If all goes well AVR will be another Edward/Medtronic competing in TARV market around 2023. What do you think the realistic valuation of the company will be? US$2-5bn? If the partner is not from one of the majors, we have better chance to go it alone.
DYOR! Not advice!
AVR Price at posting:
$7.11 Sentiment: None Disclosure: Held
(20min delay)