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Posted On: 03/13/2020 7:35:09 PM
Post# of 149108
Hulk, so a couple of things, FDA knows our drug well from all the years of trial and we are on the verge of BLA submission. They also know GILEAD drug well and should know that its already been used in China with less than desirable results, but I am under the impression they must show the public they are trying something or at least showing effort with what they have. I expect FDA to give the green light for Cytodyn next week, its been 1 week since submission, for all we know it has green light already and ready to make its first injection soon.
Quote: "It feels to me like our strategy is schizophrenic. Chasing 25 indications is great for Pfizer or Merck, but for a company made up of less than 10 people and no money in the bank, I struggle to see why we don’t just get one thing done at a time."
I am with you in some aspects but being LERO is a life saving treatment how can you not pursue that? especially we know FDA moves as snails pace and will move the goal post causing numerous delays. I certainly would like to speed things up but once the BLA is finally submitted we will be on our way. My point with this is start now, but keep you main focus on the BLA which I think they have done the best they can. Not sure how time would have been saved if no other indications were being looked at.
Quote: "It feels to me like our strategy is schizophrenic. Chasing 25 indications is great for Pfizer or Merck, but for a company made up of less than 10 people and no money in the bank, I struggle to see why we don’t just get one thing done at a time."
I am with you in some aspects but being LERO is a life saving treatment how can you not pursue that? especially we know FDA moves as snails pace and will move the goal post causing numerous delays. I certainly would like to speed things up but once the BLA is finally submitted we will be on our way. My point with this is start now, but keep you main focus on the BLA which I think they have done the best they can. Not sure how time would have been saved if no other indications were being looked at.
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