On Friday afternoon, Novartis (NYSE: NVS) gave investors some bad news regarding an experimental treatment the pharma giant bought for around $9.7 billion last December. Instead of issuing an approval decision for inclisiran, the FDA sent Novartis a complete response letter (CRL) due to an unresolved facility inspection issue. Earlier this month, the European Commission granted inclisiran approval to treat just about anyone with high cholesterol or mixed dyslipidemia under the brand name Leqvio. Unfortunately, the COVID-19 pandemic made it impossible for the FDA's inspectors to evaluate a European manufacturing site included in the application. Image source: Getty Images. As a rule, the contents of CRLs and all other communications between drugmakers and the FDA are private. The recent approval of Leqvio in the EU, though, means we can take Novartis at its word that travel restrictions are the only issue keeping the company's cardiovascular unit from launching this treatment, which is expected to generate more than $2 billion annually at its peak. Inclisiran is a first-in-class treatment originally discovered by Alnylam (NASDAQ: ALNY) that interferes with the production of a protein called PCSK9 with just two injections per year. Novartis was keen to Billion Purchase of The Medicines Company Is Bad News for Amgen">acquire inclisiran for $9.7 billion last year because the twice-annual treatment is expected to compete well with Repatha from Amgen (NASDAQ: AMGN) and Praluent from Sanofi (NASDAQ: SNY). As short-lived antibody injections that merely inhibit PCSK9, Repatha and Praluent aren't expected to measure up well to inclisiran when it comes to preventing strokes and heart attacks. While the CRL Novartis received today is disappointing, we aren't going to have a clear picture of inclisiran's commercial potential until Novartis presents long-term outcome trial results about three years from now. 10 stocks we like better than NovartisWhen investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.* David and Tom just revealed what they believe are the ten best stocks for investors to buy right now... and Novartis wasn't one of them! That's right -- they think these 10 stocks are even better buys. See the 10 stocks *Stock Advisor returns as of November 20, 2020 Cory Renauer has no position in any of the stocks mentioned. The Motley Fool recommends Alnylam Pharmaceuticals and Amgen. The Motley Fool has a disclosure policy.Source