Они подали заявку?

@Muslim80 да, максимум через 9 мес получим ответ от fda

@Yuoba спасибо! Значит ждемс)

@Yuoba я читал, что FDA готово к ускоренному рассмотрению заявки IOVA. Или ускоренно это в 9 месяцев укладывается?

@SpaceKong Day 0: Upon receipt of the application, FDA has 60 days to determinewhether the application is sufficiently complete to allow for a substantivereview. Day 60: If FDA determines the application is complete, it will be filed on Day60. If FDA determines the application is not complete (see 21 CFR314.101[d]), FDA may issue a Refuse to File (RTF) Letter by Day 60, providingthe reasons for the decision. The applicant then has 30 days to request ameeting with the FDA if desired. Day 74: The FDA will inform the applicant if there are filing review issues byissuing a letter within 14 days of the determination. This is called the Day 74letter. The Day 74 Letter states the date the application was received (whichis also the date the review clock begins), the planned review timeline, whenFDA will provide a decision on the application, and expected feedback dateson proposed labeling and post marketing commitments.