Q3 they say now:https://www.nuvasive.com/wp-content/uploads/2021/02/NSO-Precice-FSN-United-States-Biodur.pdf
It's hard to know if it's reasonable to wait for September... What do you think guys? I guess this is Q3 at best to end the tests, but it may take longer to come back? I'm thinking os just doing Precice 2 on June
This is very bad news. I know testing needs to be extensive but Q3 to finish tests? In that case we'd be lucky to have stryde widely available by Q1 next year. I don't know about different countries rules but I'd imagine some sort of approval will have to happen as well. Can anyone confirm this for EU (Greece)? I know in Asia (Korea) they require a separate approval from their local FDA, this is according to my source who spoke with Dr Lee's office.
Quote from: canterk on February 26, 2021, 03:11:53 PMThis is very bad news. I know testing needs to be extensive but Q3 to finish tests? In that case we'd be lucky to have stryde widely available by Q1 next year. I don't know about different countries rules but I'd imagine some sort of approval will have to happen as well. Can anyone confirm this for EU (Greece)? I know in Asia (Korea) they require a separate approval from their local FDA, this is according to my source who spoke with Dr Lee's office.
That's my doubt. Since the recall was voluntary, I don't know if Stryde will be available after finishing tests, or if there must be permission. If the latter, it will take to end of year at least yeah
Is it unrealistic to expect Stryde to be available in 2021?
Nuvasive has stated that testing will be completed in Q3 - So yes it is realistic!
If testing finishes in Q3, wouldn't development and distribution take several months?
What needs to be developed? As far as i've understood, it's a formal and mandatory series of tests, which they seemingly missed out on. I dont think that the nail will be modified after the tests are completed. This is also what my doctor told me. Distribution should not take that long.
Hm, my doctor informed me that they were experiences issues with material corroding and reports were anecdotally relating the depletion of material to pain in the thigh. If we assume this is the case, wouldn't they need to address that and therefore make adjustments?
This is just speculation, but i think that might be another set of problems, which may not be directly related to the recall. Maybe they will address those problems after they complete the tests and resend the nails, since it appears to be a minor problem. But hey, i'm just trying to be optimistic here.
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