why the deal stalled

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Anonymous

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The deal was almost done when the FDA began an investigation. The FDA learned that the University of Iowa had a “Quality Issue”. The partner will not agree to any terms until the FDA completes its investigation and determines that our manufacturing process is “clean” and our product is “safe”. I give it 50/50 odds
 


















It's a moot point because the FDA is not investigating a quality issue. Some disgruntled ex employee is spewing garbage so the stockholders who read this board will take the info and run with it....as they have done.

Surfaxin is a good drug, the launch was just mismanaged. A bigger company with resources and expertise could make Surfaxin fly...which is a good thing for babies, and a good thing for Aerosurf down the line. Regardless of what happens with Surfaxin, Aerosurf will be huge. No doubt. The stockholders are so uninformed about Aerosurf and it's benefits. They don't understand that intubating a baby for the purpose of giving a surfactant can be detrimental to a baby by causing chronic lung disease which is FOR LIFE. They don't understand that no other surfactant can be aerosolized because of its animal properties. They don't understand that EVERY NICU in the country will want the CAG device and ONLY Surfaxin LS can be used with the device. Translation....a high demand product with NO competition. A complete rarity in this industry. Most importantly, it will revolutionize the respiratory market. I assure you,there isn't a Neonatologist or RT in the U.S. that isn't anxiously awaiting the approval of Aerosurf. Cleaning the device is no big deal.....all ventilators and other equipment is thoroughly cleaned after every use.

The Primary Investigator, Dr. Finer is one of the best researchers in the industry. From a research standpoint, the drug is in great hands.

One potential down side to Aerosurf is the shareholders and BOD rushing this process for financial gain. The enrollment takes time and if it's all done correctly, it will pay off for everyone, especially the babies. The other threat - the people that mismanaged Surfaxin are the same people in charge of Aerosurf. If the BOD and shareholders want to ensure Aerosurf makes it through Phase 2, Phase 3 and is ultimately approved by the FDA, then they should eliminate the threat. It's that simple.
 






Nearly everything you now say about Aerosurf was said before by the company about Surfaxin.
If what you say is true regarding Aerosurf, let me ask you a question. Why isn't Surfaxin being used today in the hand held nebulizers used during the CF study? Based on what you stated, while it might not be perfect, it would be better than what is being used today.
 






is there any proof or underlying rationale supporting the claim that only Surfaxin can be aerosolized? What might it take to aerosolize an animal derived Surfactant with a conventional Jet or Mesh nebulizer?
 






The short answer is that surfactants are too viscous to be nebulized effectively. It clogs the Aeroneb (vibrating mesh nebulizer). For this reason, other alternatives were pursued by DSCO to effectively aerosolize Surfaxin.

Answer to your second question:

Surfaxin, a synthetic surfactant, can be effectively aerosolized without degradation or loss of activity. As a synthetic, it has consistent properties unlike the animal derived surfactants that have a great amount of variability in their composition and have been shown to experience a loss of activity when aerosolized.

What would it take to aerosolize an animal derived surfactant? That's the million dollar question Chiesi is trying to figure out. Even if they do figure it out (which is not likely due to the aforementioned fact of variability in its composition), that product is not even in clinical trials yet. Aerosurf is at least 1-2 years ahead of any potential competitor.

Page 5 of the following publication should be of interest to you.

http://www.neonatologytoday.net/newsletters/nt-jul12.pdf

http://www.curoservice.com/health_professionals/27th_international_workshop/pdf/NEO337354_Pillow.pdf
 






aerosurf is not all its cracked up to be. First of all Dr Finer has his doubts; just ask the people in marketing that talk to him frequently. Issues include:

8-10 vials to aerosolize; huge costs under a defined DRG

70% of the babies that receive aerosurf still need to be intubated for other reasons

The babies don’t “pink up” for a significant period of time when compared to traditional surfactants


Also Dr Finer was affiliated with Sharp Mary Burch; if he is such a proponent why don’t they buy surfaxin?

finally others are already in the process of aerosolizing other surfactants; DSCO won’t be the first based on the current delays

and YES the FDA is investigating and thats why the SVP of manufacturing is suddenly MIA and on “disability”; running from the disaster he was part of
 






It is so irresponsible for you to knowingly post false information.

1. 8-10 vials are needed because the drug is being AEROSOLIZED. The fine mist is generated over time to reach the optimal dose. Obviously 5.8 mLs wouldn't suffice. As far as a DRG, don't you think a MCO would rather pay for an aerosolized surfactant than the cost of intubating a premature baby and incurring the cost of multiple days on the vent? Let's not forget the long term cost if that premature infant develops BPD - the chances of which increase exponentially with increased days on the vent (and cost of $100k per case of BPD). Oh yeah, BPD is for LIFE...there's another thought in regard to cost. You simply can't compare apples to oranges.

2. Conclusions regarding the need for babies to still be intubated after dosing Aerosurf are premature at best. The Phase 2 study is designed to assess SAFETY and TOLERABILITY as well as the optimal therapeutic dose. Efficacy will not be addressed until Phase 3. Any conclusions made prior to the completion of Phase 2 are nothing more than speculation.

3. A synthetic surfactant doesn't have as quick of a response as a animal derived surfactant. That being said, pinking up quickly is not necessarily a good thing. A slow response is optimal to avoid complications of prematurity. A sudden dramatic increase in cerebral blood flow could cause an IVH which is obviously an SAE to be avoided. This is well documented in literature in the public domain.

4. Dr. Finer is retired, however, he moved the Research team to SMB away from UCSD. Dr. Finer does not practice at SMB nor does he even have office space. His RESEARCH has absolutely nothing to do with SMB. Surfaxin has nothing to do with the Aerosurf trials.

5. Again, others are certainly pursuing an aerosolized surfactant, no doubt. Potential problems for others include the change of properties in an animal derived product upon aerosolization (which doesn't occur with synthetic Surfaxin), and the technology to effectively aerosolize
the surfactant without it clogging due to viscosity.

If another company can bring an aerosolized surfactant to market successfully before Aerosurf, good for them. What's important is what that means for preterm infants....surfactant delivery without intubation, thereby reducing the risk of lung injury.

I'm sorry you are either:
A. Completely misinformed
or
B. Angry, thereby intentionally posting misinformation

Whether you are current employee or ex-employee, your ignorance on these matters (especially items 1-3) would be concerning if not so laughable. Get your facts straight before posting your fictional version of reality.
 






In response to your Pie In The Sky thoughts:

As far as a DRG, don't you think a MCO would rather pay for an aerosolized surfactant than the cost of intubating a premature baby and incurring the cost of multiple days on the vent?...ABSOLUTELY NOT; UNLESS THERE ARE STUDIES AND DSCO AINT GOT EM! AND YOU NEED TO GO THROUGH A PROCESS FOR A DRG....YEARS IN ADVANCE


A synthetic surfactant doesn't have as quick of a response as a animal derived surfactant. HAVE YOU TOLD YOUR SURFAXIN CUSTOMERS THIS?? IS IT IN YOUR PI?


Surfaxin has nothing to do with the Aerosurf trials. REALLY? SURFAXIN IS NOT THE DRUG THAT IS BEING AEROSOLIZED?


Whether you are current employee or ex-employee, your ignorance on these matters (especially items 1-3) would be concerning if not so laughable. Get your facts straight before posting your fictional version of reality....YOU GUYS HAVE A TON OF PISSED OFF FORMER AND CURRENT EMPLOYEES SINCE; I AM A PISSED OFF INVESTOR THAT IS TIRED OF COOPER LYING AND MANIPULATING WORDS. DSCO IS SINKING SHIP AND YOUR TIME IS OVER. ITS A SHAME THAT PEOPLE IKE YOU ARE EITHER TOO STUPID TO REALIZE IT OR STILL TRYING TO CONVINCE EMPLOYEES AND STOCKHOLDERS OF A MAKE BELIEVE DREAM WORLD....EITHER WAY ITS HORRIBLE.
 






The whole talk here on Aerosurf is nothing but futuristic under the current circumstances. This company needs a fundamental reorganization to get rid completely of the self serving, chronically inept management that brought this company down by misleading investors for 20 years, spending a mind boggling sum of more than $500 million to "develop" an unsaleable product while getting personally dirty rich. One can't help but thinking that the whole ordeal was carefully crafted to fail only that the endless "stories" would allow to trick the investors into false expectations and perpetual dilution. I bet the management was much upset that FDA finally approved the drag so they pulled all possible tricks imaginable for 3 more years to postpone the marketing. Finally the moment of truth has come and it's all but obvious - The King is naked. Spending $19 million building marketing organization seems nothing but a deliberate failure, simply one can't believe they are so stupid and stubborn to make horrendous mistakes by shear miscalculation. The saddest thing is - the management here is irreplaceable, BOD is hand picked and grossly dysfunctional, no independent director can possibly be nominated without the prior management consent. So there is not a chance any further financing will be raised to continue developing Aerosurf unless a MAJOR shake up takes place. It looks like the only option remaining is for Deerfield to recall the loan on breach of covenants, take possession of the remnants and try to re-IPO under a new management. That is of course if Aerosurf is in fact a viable product but hearing for years so many lies from Cooper and Co. one can't be sure about anything. It looks increasingly obvious that partnering with somebody on anything is a fantasy dream that the Co. has been feeding the investors for more that 10 years. It's always been close, really in advanced stages, pending, in short order and very serious, close but no cigar! Must be that anyone who gets close to understanding what a disaster this company is just runs away. One thing remains a mystery how could institutional investors accumulate more than 60% of the outstanding shares and never raise a question - WTF is going on here and let this horror to go on for 20 years! ?
 






The whole talk here on Aerosurf is nothing but futuristic under the current circumstances. This company needs a fundamental reorganization to get rid completely of the self serving, chronically inept management that brought this company down by misleading investors for 20 years, spending a mind boggling sum of more than $500 million to "develop" an unsaleable product while getting personally dirty rich. One can't help but thinking that the whole ordeal was carefully crafted to fail only that the endless "stories" would allow to trick the investors into false expectations and perpetual dilution. I bet the management was much upset that FDA finally approved the drag so they pulled all possible tricks imaginable for 3 more years to postpone the marketing. Finally the moment of truth has come and it's all but obvious - The King is naked. Spending $19 million building marketing organization seems nothing but a deliberate failure, simply one can't believe they are so stupid and stubborn to make horrendous mistakes by shear miscalculation. The saddest thing is - the management here is irreplaceable, BOD is hand picked and grossly dysfunctional, no independent director can possibly be nominated without the prior management consent. So there is not a chance any further financing will be raised to continue developing Aerosurf unless a MAJOR shake up takes place. It looks like the only option remaining is for Deerfield to recall the loan on breach of covenants, take possession of the remnants and try to re-IPO under a new management. That is of course if Aerosurf is in fact a viable product but hearing for years so many lies from Cooper and Co. one can't be sure about anything. It looks increasingly obvious that partnering with somebody on anything is a fantasy dream that the Co. has been feeding the investors for more that 10 years. It's always been close, really in advanced stages, pending, in short order and very serious, close but no cigar! Must be that anyone who gets close to understanding what a disaster this company is just runs away. One thing remains a mystery how could institutional investors accumulate more than 60% of the outstanding shares and never raise a question - WTF is going on here and let this horror to go on for 20 years! ?
 






Ha! Well said. It seems like everyone on this message board, employees, ex employees, investors are all in agreement on one thing.....Cooper and Miller have lied to us all and managed to become very wealthy doing it. Meanwhile, investors are losing money and employees are now looking for jobs. My whole point is that under the right management, these drugs may have had a chance. The question still remains.... why have Cooper and Miller not been fired? Please, Mr. pissed off investor, do you and the other investors collectively not have a voice with the BOD??!
 






Anonymous said:
The whole talk here on Aerosurf is nothing but futuristic under the current circumstances. This company needs a fundamental reorganization to get rid completely of the self serving, chronically inept management that brought this company down by misleading investors for 20 years, spending a mind boggling sum of more than $500 million to "develop" an unsaleable product while getting personally dirty rich. One can't help but thinking that the whole ordeal was carefully crafted to fail only that the endless "stories" would allow to trick the investors into false expectations and perpetual dilution. I bet the management was much upset that FDA finally approved the drag so they pulled all possible tricks imaginable for 3 more years to postpone the marketing. Finally the moment of truth has come and it's all but obvious - The King is naked. Spending $19 million building marketing organization seems nothing but a deliberate failure, simply one can't believe they are so stupid and stubborn to make horrendous mistakes by shear miscalculation. The saddest thing is - the management here is irreplaceable, BOD is hand picked and grossly dysfunctional, no independent director can possibly be nominated without the prior management consent. So there is not a chance any further financing will be raised to continue developing Aerosurf unless a MAJOR shake up takes place. It looks like the only option remaining is for Deerfield to recall the loan on breach of covenants, take possession of the remnants and try to re-IPO under a new management. That is of course if Aerosurf is in fact a viable product but hearing for years so many lies from Cooper and Co. one can't be sure about anything. It looks increasingly obvious that partnering with somebody on anything is a fantasy dream that the Co. has been feeding the investors for more that 10 years. It's always been close, really in advanced stages, pending, in short order and very serious, close but no cigar! Must be that anyone who gets close to understanding what a disaster this company is just runs away. One thing remains a mystery how could institutional investors accumulate more than 60% of the outstanding shares and never raise a question - WTF is going on here and let this horror to go on for 20 years! ?
Click to expand...

Did you get it out of your system?
 






I got off my chest for all to see especially for those who might be much closer to the core of the matter, closer to decision making that might influence the actual course of affairs, those who hold the financial leverage over the potential outcome of the 20 years old ordeal. Whoever those forces might be I hope they have got enough guts to FINALLY DO SOMETHING sensible, after all there are only very limited number of options but all of them should be centered around of 2 basic premises - purge of those at he helm instead of rewarding them with immunity and gainful employment in perpetuity and a financial and organizational restructuring, drastically cutting cost and lavish remunerations especially to the bunch of the freeloaders as this management appears to be. That needs to be done expectantly, derisively for the good of the Co. and the shareholders sake. Hope some gutsy forces shall emerge in the the next couple of days to avoid the impending disaster.
 






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