I am getting tired of hearing this type of comment. I have
I am getting tired of hearing this type of comment. I have to ask, what do you think is delaying the BLA all these months? Do you really think Nader is waking up every morning and thinking that today he should file that BLA and deciding to procrastinate and feel he will get to it later? The trial has been done for a year, the FDA is who has changed what they want to see in the BLA repeatedly. Many of these changes requiring extra data that does not exist yet. The only failing Nader has made that you can really hang a hat on is that he gives out seemingly confident projections of when it will be submitted. However, I encourage you to think about how many times Nader has been given timelines from the folks preparing the BLA and from the FDA and realize he is only relaying to info he has and know what he can push. There is absolutely nothing that supports the thought that getting a drug through a BLA is going to go smoothly on time and on budget. I don't like making excuses but the person who wants the BLA filed the most is Nader - he has no desire or benefit to delay it. Sorry if this is a course post but it is just to easy to complain without at least trying to explain the situation objectively.
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