Stupid idea to launch the drug the weekend before a Tuesday Christmas.
Nobody will be watching Monday... the trading session is only a half day. Most players will have packed it in and won't be back until after New Years. It's too late...If DSCO launches anytime before January it will just be rump covering to prevent suits.
I am certain they can change the Afectair website about 3 o'clock on Monday to show "Launched" instead of "Coming Soon". And I am certain they can get a buddy somewhere to actually place an order for a few nozzles... that is all it will take to make the statement "Afectair has launch" a true statement, and that is all it would take to short circuit any suits.. These guys may be inept, but they aren't THAT dumb.
The real question is... is there some reason Afectair hasn't already launched which would prevent DSCO from even saying it was launched by the end of the year? Such as an issue with the FDA over it's active marketing? The FDA accepted the registration of Affectair back last February, but does registration equal marketing approval? or are there additional steps between registration and approval to actually sell the device in the open market... maybe a facility inspection... labeling... use instructions... approval of training materials... maybe an environmental impact statement (ha ha ha). Maybe DSCO is going right down to the wire hoping to get that final signoff by the FDA befrore the end of the year... so they are holding off saying anything in hopes that letter comes through in time. I don't know the answer here.... does anyone have any experience in gaining approval for a medical device instead of a drug?