Small question - should the FDA approval for SavvyWire come in 2022 (since we’re already in Q4 of 2021 and it looks like they’ve just announced the Human Clinical Trial for TAVR on 10/13. I’m reading your last paragraph and trying to build a timeline in my head.
Larger question for a med device newbie - what’s the normal sequence to get a device approved here in the US? R&D -> Trials -> FDA approval -> profit?
Excellent write-up. Seems like a great opportunity and , as a cardiologist, this is square in your “circle of competence.”. My concern lies with the recent run-up in share price. Sometimes, companies this size will need to raise capital. For now, I might buy a small slither just to keep it in sight. Later, if there is an offering, I will definitely get a nice sized chunk. Thanks for putting this on our radar.
Small question - should the FDA approval for SavvyWire come in 2022 (since we’re already in Q4 of 2021 and it looks like they’ve just announced the Human Clinical Trial for TAVR on 10/13. I’m reading your last paragraph and trying to build a timeline in my head.
Larger question for a med device newbie - what’s the normal sequence to get a device approved here in the US? R&D -> Trials -> FDA approval -> profit?
Excellent write-up. Seems like a great opportunity and , as a cardiologist, this is square in your “circle of competence.”. My concern lies with the recent run-up in share price. Sometimes, companies this size will need to raise capital. For now, I might buy a small slither just to keep it in sight. Later, if there is an offering, I will definitely get a nice sized chunk. Thanks for putting this on our radar.