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BlackDoggie

07/21/17 1:31 PM

#16142 RE: fred198484 #16141

I agree with the vast majority of this, fred, as I think that the MDR market for PRO 140 is likely limited. I think the one variable or oversight may be that, depending on how the FDA chooses to label PRO 140 for combo use, there may be a larger market population than you're currently considering. In particular, for patients who show early stage resistance to a single drug class, but are still C5 only. It's clear to me that the ideal situation would be to prevent progression to C4/5 tropism and MDR by suppressing viral load earlier in the process. That said, I may have a fundamental misunderstanding of the typical progression of the disease, and this is clearly hypothetical and based on FDA choices regarding labeling. Perhaps it's unlikely, based on the FDA's insistence on MDR candidates for the P2/3 combo trial. Simply seems to me to be a very logical best and highest use for PRO 140 in a combo application.

All of this obviously assumes strong clinical data and approval, which are of course not guaranteed although I expect nothing else.
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misiu143

07/21/17 1:32 PM

#16143 RE: fred198484 #16141

IV injection is very easy if patients need few or so , it is VERY difficult , my personal observation of patients , when need to be given for many years.

Yes , Ibalizumab will be in competition with PRO 140 when is SC in combination with HAART , it will take long time for SC ( years )

It will not be a competition with monotherapy , according to Dr Chain e-mail to me , they not planning monotherapy ,
If they will change , we talking about many years.

Maraviroc is very toxic and as such not a competition ,

So far not even one patient developed serious side effect to Pro 140.

One patient ( from 30 ) on Ibalizumab , left study because of side effects.( According to website , immune problems )

Saying all of that , I am happy that patients will have those 2 medication to choose .

Much better than what they have now.

IMO only...