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SJ , you don't need to look , it was in wall stree

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Post# of 155581
(Total Views: 395)
Posted On: 05/28/2019 8:05:15 AM
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Posted By: trding
Re: misiu143 #3510
Quote:
SJ , you don't need to look , it was in wall street investors presentation ,
May 10, Dr NP said 4-5 months expected interim ,

You were right , and I confused dates , sorry .
Again at about 17:28 Dr NP said , expecting interim with TNBC in about 4-5 months.

I am sure we will know sooner since blood tests for CTC will be done every 21 days.

And Trading , yes , during shareholders meeting few days ago Dr NP said that when they will have 5 patients with reduced CTC they will apply for BTD.



Okay, great information here. So that would be September to October for interim results.

Let me just give a rough estimate on the time it takes to get data for the first 5. Assuming it takes a few weeks to get the results back for the first 3. Also assume the 3+3 design will use 2 cycles to evaluate

1) Enroll the first 3 at 350mg (for phase 1 safety)--- end of June
2) Wait 2 cycles to evaluate safety of 325mg (42 days)
3) Enroll next 3 at 525mg (I assume they will be testing for the next batch during the 42 day wait)
4) Wait 2 cycles 42 days
5) Enroll next 3 at 700mg
6) Wait 2 cycles 42 days
7) Phase 2, enroll the rest!


1) June 27th
2) Aug 8th
3) Aug 8th
4) Sep 19th (data on first 5 for at least 2 cycles)
5) Sep 19th
6) Oct 31st
7) Oct 31st

Data from the first 5 should be mid September, so that matches with their estimate. They should also have data on the 700mg group at the end of Oct (with CTC drop vs dosage)


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