Yup, The BLA will be delayed. He said: "we wan
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Posted On: 02/25/2020 2:48:09 PM
Re: I_luv_cydy #19321
Yup,
The BLA will be delayed. He said: "we want to work with FDA so everything is in the exact place they want”.
Don't want a CRL from them and, as far as I am concerned, that is fine
take your time and do it right. A CRL would be devastating, unless, of course we are selling Leronlimab for other indications.
I recon we are looking now second-third week of March for BLA.
Another interesting thing is he is still expecting the BTD decision soon (as if the submission date had not been re-set by FDA when additional data was submitted).
So, our first basket patent will be this or next week.
The BLA will be delayed. He said: "we want to work with FDA so everything is in the exact place they want”.
Don't want a CRL from them and, as far as I am concerned, that is fine
take your time and do it right. A CRL would be devastating, unless, of course we are selling Leronlimab for other indications. I recon we are looking now second-third week of March for BLA.
Another interesting thing is he is still expecting the BTD decision soon (as if the submission date had not been re-set by FDA when additional data was submitted).
So, our first basket patent will be this or next week.
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