Ray, They will try to make some money out of Imagent to survive (lots of competition in this segment makes it just a fair product, unless theirs is clearly superior which I do not know).
Oxigent partnering is problematic, J&J has first option to market.
This is kind of reassuring but it could be a drag in negotiations.
If it is as good a product as the phase II suggests the J&J option is of little consequence or even good.
Liquivent phase IIs has not being as great as it could be, due to new advances in the children ventilatory management their phase II was kind of a disaster, they were lucky not to show increase mortality
in treatment group.
They did not appropriately segmented the different groups of pediatric patients for Liquivent trials. They should have focus to a narrow well defined group, like meconiun aspiration syndrome, instead they run the whole spectrum from premature newborns to infants to children, as a phase II it was ok (lots of hindsight). But it brought a debacle to the stock, and then the J&J separation brought a second shock.
Liquivent for adults phase II data is only striking for safety. The patients in old age benefit little due to their other preexisting conditions. The phase II data made it easier to design the currently ongoing phase III to focus targets.
It seems that the FDA (my speculation)wants Liquivent to prove itself in the worst of the worst cases, instead of comparing it to current therapies (more fair and of more value in my view). They want Liquivent to bring the close to death back, and this is a very tough task (again not fair to the product, nor to the company, nor to patients, my view). Ethics justify for actual FDA approach.
Safety is a big PERCEPTION problem for this perfluorocarbons since they are so stranger molecules to biological systems. In reality they have shown very good safety even years after its use, especially in babies.
Liquivent is kind of an uncertain, Imagent will provide some oxygen, Oxygent will provide life (roughly a $5 billion market for blood substitutes only).
Disclosure: I was a shareholder. Looking to go back in. |
