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Re: None

Thursday, 08/16/2018 8:54:50 AM

Thursday, August 16, 2018 8:54:50 AM

Post# of 2487
Timeline was very clear in the conference call:
Aug 4 = last dose of trial participants.
Sept 4 (or about) = Final follow up of last participants
Current - December = Scrub interum data and gather all subsequent data then lock
By YE = Turn locked data over to Biostatistician to unblind
By Q4 = Running parallel to above, putting initial package together to meet with FDA on path forward.
Q1 2019 = If FDA approves and we go straight to NDA, expect filing in Q1
This is point where current cash get us.

Other things that were mentioned without timelines that are ongoing and major impacts:

1. Ongoing negotiations with CRO. Note:. I did find it interesting that we owe them 8.7M in unpaid bills, yet they are still working with CRMD to wrap up.
2. They are looking for a partner. Note: It was interesting that they detailed how hard it is to get a drug to market being so small.
3. They are looking for "opportunistic" financing. I found this to be an interesting choice of words.
So it looks like no major developments or PR in the drug trial, approval, or results will be announced until close to YE. But there are a lot of irons in the fire as we move towards (hopeful) approval. Still here, still bullish. Just my opinions. Good luck to all!


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