1. Why 50 patients compared to original 30 - Dr P was not very clear but he mentioned it was for clinical significance and statistical relevance but this was decided after they submitted some numbers to fda - not exactly which numbers. So fda did not make that call in vacuum and possibly saw something in numbers.
2. BLA submission - Dr P said end of Q2-2018 and Tony changed to Q2-2018 to Q3-2018
My take - most likely late Q3-2018 or Q4. Here is the reason - They need safety data for 300 patients including 50 adjunct therapy
Last patient for adjunct will be enrolled in Dec’2017 - 24 weeks data will take to Jun 2018 They will need some 200+ patients from mono and they will be enrolled in Q1-2018 - their 6 months will take you to Q3-2018
Then comes topline results - full analysis (at least 6-8 weeks as needed for interim analysis of 40 patients)and creation of package - typically even for simole products it takes 3+ months to create package (if everything is ready)
Add all this and you reach Q4-2018 at the minimum
So I do not think BLA will be submitted even in Q3-2018
3. GVHD - this actually is looking more promising - the interim analysis after 10 patient will be really exciting - this will really tell efficacy - as he mentioned if the efficacy is observed it may become open label
This is better opportunity for collaboration
4. Funding answers were wishy-washy - not confidence building - more dilution and r/s coming
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