Why does everyone keep saying this has only a 50/50 of getting the approval? Are people afraid to be wrong? They have gotten FDA approval on Surfaxin before. They just need to provide updated information. The chances of them not getting the approval seem extremely thin. I think there is a 50/50 chance on making the right decision and the wrong decision. The wrong decision is NOT buying DSCO.
Jeeze, Hetero, let me spell it out for you since you apparently cannot or will not read anything for yourself.
First, DSCO got approval for Surfaxin a year and a half ago, not last Spring like you said in aother thread.
Second, The release was delayed because DSCO needed to "supply updated proof", not the other way around like you posted in another thread.
Third... and why it is assumed to be 50/50.... This is about the third or fourth time DSCO has changed the specs on Surfaxin. Last time it was so bad that the FDA questioned whether the Surfaxin made today at DSCO's Totowa facility was the same as that made by
Akorn back in 2003 for the Phase III trials. After two runs at it, the FDA finally accepted that it was. Then, between approval and launch, DSCO wants to change the specs again!. Foot - Shoot - Ouch!
Now, AFTER APPROVAL, and AFTER submitting the post approval changes to the FDA, twice, DSCO is dumping the Totowa facility and going with a contract manaufacturer. In mid July (after sending the packet to the FDA) DSCO arranged an extension of the Totowa lease for only 18 more months - thru middle of 2015 (for which the landlord required them to pay,,, the entire lease... up front. Smart landlord). Then, in early August, DSCO signed a manufacturing agreement with a contractor (DMS Inc) to produce Surfaxin from scratch (ie: from raw ingredients)
Soooooo, assuming DSCO obtains FDA approval for the current changes.... another round is coming in less than a year to get the process started to get the FDA to re-re-re-approve the manufacturing process the way DMS will do it....
Does this sound like a company focused on getting a product to market or just a never ending slew of "burning cash while waiting for the FDA to respond"?
And if DSCO were to actually start the Phase II trials for Aerosurf this year, whose product would they use?
Answer: DSCO is no longer promising to start the Aero trials this year. That quietly died after the stock placement was complet
Dutch, can't seem to verify your DMS news although I don't doubt it. It would seem such a switch also allow them in the future to retire their medical affairs personnel since DMS seems able to provide that service (certainly able to hand out plastic nozzles). Eliminating Totowa/Medical Affairs groups could be expected to keep more cash on hand for executive salaries (I mean reduce cash burn).
As I recall liquid surfaxin is no longer under patent while lyophylized version is still under patent protection (I think). If DMS can manufacture liquid surfaxin so can everyone else (as generic). Always wondered about their commercialization strategy....however I assumed they were actually going to market.