Well... good thing we arent using SYRINGES R US.
Post# of 148174
(Total Views: 900)
Posted On: 07/13/2020 5:28:47 PM
Well... good thing we arent using SYRINGES R US. Un freaking believeable that the FDA's comment hanging things up is the name of the syringe manufacturer. (that apparently was in the package and just "missed" by someone. I know this type of bureaucrat. wait till the last minute for response and send a BS request that ultimately was in the BLA just to kick the can down the road. "oh sorry, i didnt see that..." i can hear it now.)
Also from reading between the lines, i think the analysis they are requesting most likely comes down to a bigger spreadsheet with more columns of the same data that is in the BLA. "well... it would make it easier to analyze if it was presented on the same sheet"
I see this everyday in the construction industry waiting on building permits to be approved by people who are not really qualified to review construction drawings. They find the misspelled words but miss the fire wall concerns.
And NP has to do the CEO routine and say how much the FDA is helping and how great they are. It is literally margaret in record keeping in cube 2305 on the 5th floor that wants another box checked so it can be resubmitted where it will proceed to sit on someones desk for 4 months, rubber stamped to sit on another desk for 1 month and so on and so on, until the deadline gets reached and miracuously gets processed across 5 additional desks in 2 weeks.
I s*** you not! I bet you 10,000 shares that is basically what this comes down to.
These comments from the FDA were not substantive at all and actually ridiculous. The biggest error was PRing this without better messaging.
"FDA is requesting syringe manufactuer name as well as current clinical data to be presented in an alternative manner to facilitate FDA process review. Cytodyn will provide this information ASAP." Done!
Also from reading between the lines, i think the analysis they are requesting most likely comes down to a bigger spreadsheet with more columns of the same data that is in the BLA. "well... it would make it easier to analyze if it was presented on the same sheet"
I see this everyday in the construction industry waiting on building permits to be approved by people who are not really qualified to review construction drawings. They find the misspelled words but miss the fire wall concerns.
And NP has to do the CEO routine and say how much the FDA is helping and how great they are. It is literally margaret in record keeping in cube 2305 on the 5th floor that wants another box checked so it can be resubmitted where it will proceed to sit on someones desk for 4 months, rubber stamped to sit on another desk for 1 month and so on and so on, until the deadline gets reached and miracuously gets processed across 5 additional desks in 2 weeks.
I s*** you not! I bet you 10,000 shares that is basically what this comes down to.
These comments from the FDA were not substantive at all and actually ridiculous. The biggest error was PRing this without better messaging.
"FDA is requesting syringe manufactuer name as well as current clinical data to be presented in an alternative manner to facilitate FDA process review. Cytodyn will provide this information ASAP." Done!
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Lamont
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Lamont
#1 30.58333 114.26667
#2 39.002744, -77.103470
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