(Total Views: 366)
Posted On: 04/18/2019 12:35:21 PM
Post# of 151556
And BTW , doing now density tests for every patients for pivotal , and dose patients 525 or 700 depending on the results should not be done now
( except if required by FDA )
, it is much more risky since we have no experience how accurate this test is now .. Very new test , not proven for some time and many patients as it should be for such an important study ,,
I will do 700 mg to all patients , approve the medicine , even unofficially do the tests to see how well it is correlating ...
And tune up the treatment later ...
Of course all IMO only...
( except if required by FDA )
, it is much more risky since we have no experience how accurate this test is now .. Very new test , not proven for some time and many patients as it should be for such an important study ,,
I will do 700 mg to all patients , approve the medicine , even unofficially do the tests to see how well it is correlating ...
And tune up the treatment later ...
Of course all IMO only...
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