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No concrete news but some side items 1. Cancer

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Amatuer17   Saturday, 07/11/20 06:55:36 AM
Re: Chuckles759 post# 92980
Post # of 119272 
No concrete news but some side items

1. Cancer BTD - they have to submit much more information to FDA - so it will take longer time

2. Product concentrate shelf life is very long - Vial shelf life is around 2 years. First batch of 30000 from Samsung should come in 3 weeks- thereafter 1.1 million vials in batches of 200-300k

3. M2M results by next week end earliest or can go to week after next

4. DSMB - it was not clear. He kind of mentioned that DSMB was being formed. So timeline for that result was not clear

5. M2M is phase 2 so FDA may ask for phase 3 as he does not think FDA will consider it unmet need.

6. Mexican trial not yet started, Brazil trial no concrete progress

7. Combo BLA - he still says tha Jul 10th was the date by which PDUFA date should be received

8. HIV MONO - he gave long explanation but not sure he mentioned anything about starting pivotal trial

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