Of course, Shire says they will submit for Phase III. And, they will. However, the Feds will insist on another Phase II; appropriately so as the secondary target results are not impressive.
It will take 5 years to evaluate the long term results of the PremiPlex study. Maybe, a new study will start after that. INSM was lucky to get $11 million for PremiPlex. That is when I sold my INSM shares.
Welcome to biotech investing. It is dangerous to your financial health. IMHO
The results are disappointing for ROP and "The secondary endpoint of time to discharge from neonatal intensive care was not met."
There seems to be another factor (protein?, hormone?. O2?) that is also missing. PremiPlex is not enough on its own.
Terry has been trying to tell this message board that biotech is not magic. It is one thing to be hopeful, it is another to think that these results indicate anything positive for INSM. Not hopeful for Shire either.
It will be difficult to justify a Phase III study on the results posted so far. Shire will be lucky to get a Phase II study as the theory supporting the use of PreiPlex is not demonstrated in the results as revealed so far.