One may even think that this could be the strategy
Post# of 153771
(Total Views: 543)
Posted On: 04/11/2020 3:11:37 PM
One may even think that this could be the strategy they are going with...
CYDY Move...spotlight and exposure
-Refrain from submitting BLA until yes/no on emergency approval for covid
-Share news far and wide to get exposure on drug and put spotlight on FDA decision regarding leronlimab
FDA's Move...approve or ask for more data
-->if approval-spotlight is directly on the FDA...we then submit the BLA with all eyes watching (no monkey business and lot's of pressure to approve given the safety record and results)
-->if more data required-we continue to get exposure as everyone shares the positive stories (i.e. LA story last night) and pressure continues to build on FDA as results continue to be positive...then we file the BLA which although not in the direct spotlight still benefits from the pressure to approve
In both of these situations, but especially the former, there is also the opportunity for political intervention as politicians want this to end and for us to get back to work.
My hunch is that a lot of maneuvering is going on behind the scenes. Even though we are small, there are some smart people associate with this company and I think they are taking all the information they have into account (i.e. performance of other drugs in covid and previous interactions with the FDA) and trying to make the best moves they can with the highest probability of getting us approved and on the market.
Anyhow, just my .02
CYDY Move...spotlight and exposure
-Refrain from submitting BLA until yes/no on emergency approval for covid
-Share news far and wide to get exposure on drug and put spotlight on FDA decision regarding leronlimab
FDA's Move...approve or ask for more data
-->if approval-spotlight is directly on the FDA...we then submit the BLA with all eyes watching (no monkey business and lot's of pressure to approve given the safety record and results)
-->if more data required-we continue to get exposure as everyone shares the positive stories (i.e. LA story last night) and pressure continues to build on FDA as results continue to be positive...then we file the BLA which although not in the direct spotlight still benefits from the pressure to approve
In both of these situations, but especially the former, there is also the opportunity for political intervention as politicians want this to end and for us to get back to work.
My hunch is that a lot of maneuvering is going on behind the scenes. Even though we are small, there are some smart people associate with this company and I think they are taking all the information they have into account (i.e. performance of other drugs in covid and previous interactions with the FDA) and trying to make the best moves they can with the highest probability of getting us approved and on the market.
Anyhow, just my .02
(3)
(1)