Anika needs to focus on China, India, Russia, Brazil, Egypt, Japan, Germany, South Korea for osteoarthritis and Monovisc (that's where alot of osteo is). For the US, Anika needs to switch gears and ramp up Cingal, which will replace Monovisc anyway and will be a better product.
Monovisc would likely replace Orthovisc sales, so this refusal is fairly meaningless. Not so meaningless, since it implies a problem with the fda in this sector and maybe also this company. Mitek should handle the Cingal fda process!
Meanwhile a record quarter was promised without monovisc.
I agree anyone but Anika should handle the FDA. I think ANIK will go back up to $14 without Monovisc, and still has upside with their pipeline. I also agree that Monovisc would replace Ortho sales, but Genzyme's Synvisc, the competitor to Monovisc, has sales over $200 million. So either the product (Mono) is just not up to snuff, or the sales effort is dismal, or docs really would rather (as one poster suggested) sell Orthovisc because it's 3 injections instead of 1.