From yesterday PR.. " Primary endpoint--- overa
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Posted On: 02/22/2020 8:05:45 AM
From yesterday PR..
" Primary endpoint--- overall response rate..
Strong response signal seen in a sub study may allow for expansion to generate data that could potentially support market approval "
Someone asked question yesterday , how much longer patient must live to satisfy secondary endpoint in cancer study..--
FDA don't need to wait to see how many more months or years patients will be alive ,
If they see that on MRI and scans , tumors are shrinking , no new metastasis , this should be enough for them.
This is a sign that patients life is prolong , and it is accepted sign by FDA.
With Leronlimab , so far we can see shrinking tumors , some gone and no new metastasis withing few weeks after starting therapy ,
If this will mostly continue in our basket trial , since we dealing with the most deadly cancers ,
this should not be a very long study..
IMO as always.
" Primary endpoint--- overall response rate..
Strong response signal seen in a sub study may allow for expansion to generate data that could potentially support market approval "
Someone asked question yesterday , how much longer patient must live to satisfy secondary endpoint in cancer study..--
FDA don't need to wait to see how many more months or years patients will be alive ,
If they see that on MRI and scans , tumors are shrinking , no new metastasis , this should be enough for them.
This is a sign that patients life is prolong , and it is accepted sign by FDA.
With Leronlimab , so far we can see shrinking tumors , some gone and no new metastasis withing few weeks after starting therapy ,
If this will mostly continue in our basket trial , since we dealing with the most deadly cancers ,
this should not be a very long study..
IMO as always.
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