Some facts first:
Initially FDA told us that a face-to-face meeting was not possible and, in order to accelerate things, WRO was forthcoming before September 4, they answered on September 1 AND scheduled a Type A meeting on September 8.
Conclusion: Something important has come out inside FDA as they answered in writing and scheduled a prompt meeting (suddenly this is possible now).
What is it ?? It has to do with dosage as stated in the communication. As we obtained better results with 700mg than with 350mg & 525mg (and we understood at the time that LL’s half-life in the body was different, we phased patients more effectively from HAART to LL) the FDA told us to “try” 700mg as they wanted more than 70% for 48 weeks with a modified overlap so the virologic failures @10 weeks were reduced (if I remember correctly).
Once we submitted our 700mg integrated assessment in support for the BLA application something has come out. And they want to talk about it as all of the sudden a face-to-face is possible and pronto.
What is it??? Well, something that requires a multidisciplinary assessment.
As in statisticians and clinicians. Or put it in another way: we are not sure if it is going to be 700mg or another dosage … all this, of course, imho
The way I see it the good news is FDA is reaching a conclusion … finally. The bad news is that they haven’t, after all the loops they have put on our way have not lead to 700mg … yet.
I don’t want to qualify here what FDA has done and is doing to us as will create a discussion that is not worth having.
Which begs the question: why did we applied for HIV combination therapy with 350mg weekly dose in the U.K. ???
Answer: because we have the whole “enchilada” for this dosage and we think we have more probability to be approved with 350mg.
Which begs the question (once more): Is there a possibility that FDA will approve 700mg for the USA and MHRA goes with 350mg??
No way Jose.
What yields ????
Stay tuned, this will be a very interesting week.
And, by the way: NP said before that he was going to bring in the subject of monotherapy in the meeting with FDA. Go Nader, go !!!!
Initially FDA told us that a face-to-face meeting was not possible and, in order to accelerate things, WRO was forthcoming before September 4, they answered on September 1 AND scheduled a Type A meeting on September 8.
Conclusion: Something important has come out inside FDA as they answered in writing and scheduled a prompt meeting (suddenly this is possible now).
What is it ?? It has to do with dosage as stated in the communication. As we obtained better results with 700mg than with 350mg & 525mg (and we understood at the time that LL’s half-life in the body was different, we phased patients more effectively from HAART to LL) the FDA told us to “try” 700mg as they wanted more than 70% for 48 weeks with a modified overlap so the virologic failures @10 weeks were reduced (if I remember correctly).
Once we submitted our 700mg integrated assessment in support for the BLA application something has come out. And they want to talk about it as all of the sudden a face-to-face is possible and pronto.
What is it??? Well, something that requires a multidisciplinary assessment.
As in statisticians and clinicians. Or put it in another way: we are not sure if it is going to be 700mg or another dosage … all this, of course, imho
The way I see it the good news is FDA is reaching a conclusion … finally. The bad news is that they haven’t, after all the loops they have put on our way have not lead to 700mg … yet.
I don’t want to qualify here what FDA has done and is doing to us as will create a discussion that is not worth having.
Which begs the question: why did we applied for HIV combination therapy with 350mg weekly dose in the U.K. ???
Answer: because we have the whole “enchilada” for this dosage and we think we have more probability to be approved with 350mg.
Which begs the question (once more): Is there a possibility that FDA will approve 700mg for the USA and MHRA goes with 350mg??
No way Jose.
What yields ????
Stay tuned, this will be a very interesting week.
And, by the way: NP said before that he was going to bring in the subject of monotherapy in the meeting with FDA. Go Nader, go !!!!
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