Subject: Re: TB REACH V7 Application for your review and comments
From: Vivian Cox <[email-masked]>
To: Tamar Gabunia <[email-masked]>
Cc: Nelly Solomonia <[email-masked]>, Nestan Tukvadze <[email-masked]>, Nino Lomtadze <[email-masked]>, Vivian Cox <[email-masked]>, Maka Danelia <[email-masked]>, Irma Khonelidze <[email-masked]>, Mari Buziashvili <[email-masked]>, Zaza Avaliani <[email-masked]>, Natalia Adamashvili <[email-masked]>, "[email-masked]" <[email-masked]>
Date: Thu, 29 Aug 2019 07:53:47 +0000

Hello all,
Please find my edits/comments merged in with those of Nelly and Tamar’s excellent inputs.  I think Tamar raises a critical point that we need to clarify more specifically why we are asking for additional funding to implement BPaL programmatically, especially if we are arguing that Georgia already has robust clinical, lab, and trial infrastructure.  This will likely become more clear as the budget is detailed, but will need to be added to our executive summary and section 4.2 (activities).  I also added some descriptions of how we plan to observe and document our observations of the ‘programmatic challenges’ accompanying BPaL introduction into section 4.2 (underreported objective #4), but please feel free to add to this if you can think of others.  This is one of the main arguments we are using to say our proposal is unique - we will test the use of BPaL and learn early lessons on how to use it programmatically - so we should have an objective that describes how we are going to document this.

Under section 8.6, I think we could add that the high quality, ‘real world evidence’ or ‘real world data’ we collect on the patients that receive BPaL can be submitted to WHO in future as a sizable cohort to contribute to future WHO recommendations on BPaL use.

I will review sections 5 and 8 and return comments on them later today.  Thanks, Vivian