I am a dreamer... but maybe you could give me the
Post# of 153822
(Total Views: 664)
Posted On: 07/15/2020 12:11:24 PM
I am a dreamer... but maybe you could give me the definition of what exactly a rolling review is? We were granted this rolling review process to review our BLA as an on going review for the duration of our application process. That hasn’t stopped.
It’s just my opinion. I have a hard time believing that it means nothing now. It took them 2 months of reviewing our application to find the issues with it. Do you think they just thumbed through it and said where is that 700 mg dose. I don’t see it... put it back on the shelve. We will teach them to file without all the information they know we want! Let’s be realistic. Average BLA is 100,000 pages over the duration of all the testing. Do you really think they are not trying to get ahead of the curve and reviewing everything else we submitted while they wait for the rest of the information they asked for? They have reviewed us along the whole process so far and had meetings to suggest different dosages and other information they would like to see. I am betting they just don’t shelve it on a technicality. Would seem pretty substandard if they put it on the back shelve as a penalty when lives depend on advancing the cause of a working therapeutic for covid.
They already recognize the safety of HIV duel therapy by what we have had reviewed previously. That is suppose to be the reason we had small trial numbers required. Because of our safety record to date is my understanding. I don’t believe they are not getting ahead of the work load of the complete review just because we lacked a couple small items they requested.
It’s just my opinion. I have a hard time believing that it means nothing now. It took them 2 months of reviewing our application to find the issues with it. Do you think they just thumbed through it and said where is that 700 mg dose. I don’t see it... put it back on the shelve. We will teach them to file without all the information they know we want! Let’s be realistic. Average BLA is 100,000 pages over the duration of all the testing. Do you really think they are not trying to get ahead of the curve and reviewing everything else we submitted while they wait for the rest of the information they asked for? They have reviewed us along the whole process so far and had meetings to suggest different dosages and other information they would like to see. I am betting they just don’t shelve it on a technicality. Would seem pretty substandard if they put it on the back shelve as a penalty when lives depend on advancing the cause of a working therapeutic for covid.
They already recognize the safety of HIV duel therapy by what we have had reviewed previously. That is suppose to be the reason we had small trial numbers required. Because of our safety record to date is my understanding. I don’t believe they are not getting ahead of the work load of the complete review just because we lacked a couple small items they requested.
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