RE: RX vs OTC25 Jul 2020 14:57
theItalian, who would underwrite the marketing budget if not the licensee?..certainly not FUM (it isn't in their business model & they don't have the resources anyway).
All this 'talk' about FUM getting EU regulatory approval late this year or early next may be wishful thinking. Unless EU regulators have changed their modus operandi, things often take longer than expected (IMO). There is the possibility the regulator asks for more information or additional data (similar to the FDA), as one 'expert' source wrote, ".... as medical device filings are usually approved or not within 6 months of filing." So FUM might wait 6 months, just to be told the application has failed - for some 'unexpected' reason - at which point FUM would have to amend their application and start the waiting process again. At least the FDA approach avoids that 6 month delay...they tell you of any shortcomings at the start.