AVITA Medical Submits Response to FDA, Resuming Review Clock for RECELL GO PMA Supplement [Yahoo! Finance]
Avita Medical, Inc. (RCEL)
Company Research
Source: Yahoo! Finance
focused on first-in-class devices for wound care management and skin restoration, today announced it has submitted its response to the U.S. Food and Drug Administration (FDA) for additional information requested in connection to its premarket approval (PMA) supplement for RECELL GO ™ . This submission resumes the substantive interactive review process under the Breakthrough Devices Program. The response addresses various questions and incorporates data from in-house testing to support the PMA supplement and fulfil the additional information request, which we received in October of 2023. Upon receipt by the FDA, the application of the PMA supplement resumes its 180-day real time review, with 90 days remaining in the review period. Therefore, we expect FDA approval on May 30, 2024, positioning us for a product launch on May 31, 2024. “RECELL GO will enhance our capabilities and reach to continue our already impressive growth,” said Jim Corbett, Chief Executive Officer of AVITA Medic
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News
- AVITA Medical to Announce First Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- AVITA Medical to Announce First Quarter 2024 Financial ResultsGlobeNewswire
- AVITA Medical, Inc. (NASDAQ: RCEL) was downgraded by analysts at BTIG Research from a "buy" rating to a "neutral" rating.MarketBeat
- AVITA Medical Updates Expected First Quarter 2024 Revenue [Yahoo! Finance]Yahoo! Finance
- AVITA Medical Updates Expected First Quarter 2024 RevenueGlobeNewswire
RCEL
Earnings
- 2/22/24 - Beat
RCEL
Sec Filings
- 4/23/24 - Form DEF
- 4/23/24 - Form ARS
- 4/11/24 - Form 8-K
- RCEL's page on the SEC website