RE: BLA delay ... I agree with previous poste
Post# of 153832
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Posted On: 01/22/2020 4:57:16 PM
RE: BLA delay ...
I agree with previous posters that it is frustrating. Particularly, as always, in regard to setting timeline expectations and failing to meet them. For my part, I'd prefer no timeline given than a timeline given and then missed, but reasonable people can differ.
I console myself on BLA delay by thinking that it is possible that these "delays" are, in part anyway (e.g., clinical portion), a sort of "rolling review" where the company and the FDA are working hand-in-hand to generate the best possible BLA product the first time around.
In other words, what do we really care about as investors? Time to approval. So, if these delays in submission shorten the time between submission and approval, then who cares about the "delay"? Better put, was it even a delay?
Again, this is my OPTIMISTIC way of looking at it (not my default setting). My default outlook is that it will be 6 months from submission to approval, and I am impatiently waiting for the PR that announces the full BLA has been submitted AND accepted by the FDA.
I've also recently been considering whether and to what extent the FDA's apparent dosing indecision on the combo BLA is impacted, at all, by the 700 mg dose used in cancer.
Will, for example, a combo approval at 700mg make it easier for the FDA to justify giving accelerated approval in cancer at that dose? Could this be one of the reasons why the FDA has requested more and more data from the CD03 monotherapy investigatory trial (much of which is at 700 mg)?
Admittedly, these are both OPTIMISTIC takes. The two (BLA and accelerated approval down the road in cancer) most likely are completely unrelated, but I am in a speculative mood today and thought I'd share my thoughts.
I agree with previous posters that it is frustrating. Particularly, as always, in regard to setting timeline expectations and failing to meet them. For my part, I'd prefer no timeline given than a timeline given and then missed, but reasonable people can differ.
I console myself on BLA delay by thinking that it is possible that these "delays" are, in part anyway (e.g., clinical portion), a sort of "rolling review" where the company and the FDA are working hand-in-hand to generate the best possible BLA product the first time around.
In other words, what do we really care about as investors? Time to approval. So, if these delays in submission shorten the time between submission and approval, then who cares about the "delay"? Better put, was it even a delay?
Again, this is my OPTIMISTIC way of looking at it (not my default setting). My default outlook is that it will be 6 months from submission to approval, and I am impatiently waiting for the PR that announces the full BLA has been submitted AND accepted by the FDA.
I've also recently been considering whether and to what extent the FDA's apparent dosing indecision on the combo BLA is impacted, at all, by the 700 mg dose used in cancer.
Will, for example, a combo approval at 700mg make it easier for the FDA to justify giving accelerated approval in cancer at that dose? Could this be one of the reasons why the FDA has requested more and more data from the CD03 monotherapy investigatory trial (much of which is at 700 mg)?
Admittedly, these are both OPTIMISTIC takes. The two (BLA and accelerated approval down the road in cancer) most likely are completely unrelated, but I am in a speculative mood today and thought I'd share my thoughts.
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