I am excited about news on Nov 5th. What could i
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Posted On: 11/02/2020 4:19:13 PM
I am excited about news on Nov 5th.
What could it be? My hope is that they filed the equivalent to our HIV BLA in the U.K. and the clock will start ticking for approval. Of coarse more news is possible too. Maybe Canada has asked us to file also? Maybe the EU? Updates on enrollment? Everything is getting more and more exciting for us all. I am sure these other countries can’t wait for our CD-12 results either. To approve us before the results of the CD-12 at the 75% interim review would legitimize Leronlimab and give it international exposure.
If memory serves me, the U.K. has a fairly quick approval process once filed.
14 days to accept said filing.
Then 60 days to approval.(If approved)
If this holds true, we could have our first approval for Leronlimab in a little over 2 months. It’s possible and hopeful. Way quicker than our slow FDA and 10 months or if your lucky to ask for a 6 month review.
Hopefully Our new Science officer has reviewed and changed any needed information for our submittal to be accepted on our first try. He has the background of a hired gun to get us over the finish line. We should be very thankful for his help and experience when we need it most.
This is a pivotal point in time in my opinion. One where we look back and remember where we officially started the progression of many approvals for Leronlimab!
What could it be? My hope is that they filed the equivalent to our HIV BLA in the U.K. and the clock will start ticking for approval. Of coarse more news is possible too. Maybe Canada has asked us to file also? Maybe the EU? Updates on enrollment? Everything is getting more and more exciting for us all. I am sure these other countries can’t wait for our CD-12 results either. To approve us before the results of the CD-12 at the 75% interim review would legitimize Leronlimab and give it international exposure.
If memory serves me, the U.K. has a fairly quick approval process once filed.
14 days to accept said filing.
Then 60 days to approval.(If approved)
If this holds true, we could have our first approval for Leronlimab in a little over 2 months. It’s possible and hopeful. Way quicker than our slow FDA and 10 months or if your lucky to ask for a 6 month review.
Hopefully Our new Science officer has reviewed and changed any needed information for our submittal to be accepted on our first try. He has the background of a hired gun to get us over the finish line. We should be very thankful for his help and experience when we need it most.
This is a pivotal point in time in my opinion. One where we look back and remember where we officially started the progression of many approvals for Leronlimab!
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