(Total Views: 421)
Posted On: 12/05/2019 2:58:52 PM
Post# of 155792
I like NP's interviews as they "keep the wood in the fire" to put it in some way and simultaneusly let us know where we stand (good or bad).
This explains why he is saying end of December or earlier for BLA delivery. We are waiting on FDA's direction.
That is, time consuming, this is a 12 years USA HIV deal. I hope is properly negotiated to protect all of us (investment wise and medically wise.)
OK, so the negotiations are alive and now very advanced. That is what I want to hear
So package is very complex and there is need for time. Important thing is everything is "on rails". No rush but finish it
Good to hear, the BLA will go to FDA soon and, if approved we will be financially safer next year.
Quote:
"Hopefully, in a few days we will get direction on which dose we will submit the BLA for and that will take us to the end of December for clinical trial section,"
This explains why he is saying end of December or earlier for BLA delivery. We are waiting on FDA's direction.
Quote:
"We've signed a non-binding agreement to license out the sales of the product in the United States," said Dr. Pourhassan. "The process is very extensive
That is, time consuming, this is a 12 years USA HIV deal. I hope is properly negotiated to protect all of us (investment wise and medically wise.)
Quote:
the Company expects to have the process finalized any day
OK, so the negotiations are alive and now very advanced. That is what I want to hear
Quote:
It takes 6 months usually to have an agreement like that. Hopefully very soon.
So package is very complex and there is need for time. Important thing is everything is "on rails". No rush but finish it
Quote:
"Everything is going well. We need to just make sure that we get the approval and start having revenue - hopefully in 2020,"
Good to hear, the BLA will go to FDA soon and, if approved we will be financially safer next year.
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