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| Alias Born | 10/28/2013 |
Monday, February 15, 2016 10:34:22 AM
I think they would be selling the product to Northwest, not competing with Northwest.
Right now Northwest is protecting IP for some reason. Whatever the reason, it would likely weigh on LP's decision as to whether to have Northwest own that product, or start a new, small company.
I think the reason they are protection IP right now is because there is an unblinding in process, initiated by the FDA. Though the look at data was probably not for the purpose of determining futility for DCVax-L, that would be a possible outcome, however remote.
It might take the DMC and the host company to make a decision about AA or application thereof, but I think the FDA is obligated to make a call on futility if they see it. Kind of like a police officer being obligated to arrest you if he sees illegal drugs growing in your window. They may not have the right to entry to look for such, but they have the obligation to act if they see it for whatever reason.
The chances of a finding of utility may be super slim, but it would be in character for LP to go into a defensive stance however slim those chances. What to lose? What to lose would be trust in the investor base, but perhaps she just doesn't weigh that very high compared to even the slim odds of losing everything... thus the positioning of the patents during this alleged look at the data by the FDA (probably for gauging relative efficacy of Celldex's drug).
Right now Northwest is protecting IP for some reason. Whatever the reason, it would likely weigh on LP's decision as to whether to have Northwest own that product, or start a new, small company.
I think the reason they are protection IP right now is because there is an unblinding in process, initiated by the FDA. Though the look at data was probably not for the purpose of determining futility for DCVax-L, that would be a possible outcome, however remote.
It might take the DMC and the host company to make a decision about AA or application thereof, but I think the FDA is obligated to make a call on futility if they see it. Kind of like a police officer being obligated to arrest you if he sees illegal drugs growing in your window. They may not have the right to entry to look for such, but they have the obligation to act if they see it for whatever reason.
The chances of a finding of utility may be super slim, but it would be in character for LP to go into a defensive stance however slim those chances. What to lose? What to lose would be trust in the investor base, but perhaps she just doesn't weigh that very high compared to even the slim odds of losing everything... thus the positioning of the patents during this alleged look at the data by the FDA (probably for gauging relative efficacy of Celldex's drug).
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