Well I guess with today's PR, all the pumpers finally realized that the "presentation" at the PAS meeting was not for liquid Surfaxin... uh, that would be the drug DSCO has been "approaching" the FDA with for the past 7 or 8 years.
The drug was Aerosurf, the aerosolized version of Surfaxin. So, yes, the drug worked on the little piggies like liquid Surfaxin did... a decade ago. But Aerosurf will never see the light of day unless and until liquid Surfaxin gets approved. That is something DSCO has been unable to accomplish.
The FDA will let DSCO do all the testing it wants.. on animals. But the FDA won't let DSCO do any more human testing of liquid Surfaxin. Not because it doesn't work... it does. But because the FDA wants DSCO to complete the connection to the original Phase III trials by proving that it works the same on fetal rabbits and preterm lambs. DSCO used lambs during the 2003 trials, not rabbits. the FDA requires rabbits.
Bad trial design.
So, now that the little day traders have their news, the point-to-point comparison remains an unachieved goal. And that is all that really matters. The data sets must match. They haven't for 6 years. But they must... or else DSCO is just squandering more money keeping this train on the tracks. They cannot turn, they cannot stop, they dare not even slow down... they must keep going... all the way to the scene of the crash. And they will have passenger cars full of day traders the day it happens. Management will eventually walk away once all the possible cash is wrung out of this... the passengers will be left in the smouldering wreck... wondering what the h$ll happened????