Hi, No I don't think so.
FDA provided a CRL (complete response letter), and now we await approval from FDA.
The company (BOT) could provide more detail around what it has done in response to the CRL. However they have already done this via webinars at the time of the the CRL and one in the last few weeks, etc in the past few months.
They have a meeting with the FDA scheduled next week or so, then approval by 20th June.
Do they have to advise on their meeting with the FDA in the next week? I don't think they have to, (but perhaps they will - just to say all is well full steam ahead.
Hi, No I don't think so. FDA provided a CRL (complete response...
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