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Bonesuppport: Internal FDA delays push decision date - Redeye

Redeye does not consider the delay to entail any particular negative impact on the eventual US launch of CERAMENT G. The FDA is still affected by the pandemic and the delay does not reflect any concerns about this specific application. We are confident in a US launch in Q3 following an anticipated approval in the coming weeks (probably 2-5, according to us). We reiterate our Base Case of SEK 80 per share.

Redeye does not consider the delay to entail any particular negative impact on the eventual US launch of CERAMENT G. The FDA is still affected by the pandemic and the delay does not reflect any concerns about this specific application. We are confident in a US launch in Q3 following an anticipated approval in the coming weeks (probably 2-5, according to us). We reiterate our Base Case of SEK 80 per share.
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