I don't usually like starting new threads, but I feel this is a worthy topic for discussion.
Approval from the FDA to commence Phase 2 trials, starting with Angelman (AM) here in Australia, is imminent. I'm being positive and expect the FDA to give the all clear based on the submission of revised safety protocols. This should then clear the path for approvals for Phelan McDermott (PM), Pitt Hopkins (PH) and Prader Wiilli (PW).
Assuming the above, there will be a significant amount of news flow over the coming 18 months- FDA approval to commence trial, first patient enrolled, last patient enrolled then results. Four lots of announcements per syndrome multiplied by the 4 syndromes is 16 pieces of news flow. I've assumed month 1 FDA approval, month 2 first patient, month 6 last patient then month 10 results. The company will more than likely announce in HY's, so their band could be a time period of 7 months to 17 months.....my assumption is a 10 month timeframe.
So, what's the news flow look like;
Mar 22 - AM FDA approval
Apr 22 - PM FDA approval
Apr 22 - AM first patient
May 22 - PH FDA approval
May 22 - PM first patient
Jun 22 - PH first patient
Aug 22 - AM last patient
Sep 22 - PW FDA approval
Sep 22 - PM last patient
Oct 22 - PW first patient
Oct 22 - PH last patient
Jan 23 - AM results
Feb 23 - PW last patient
Feb 23 - PM results
Mar 23 - PH results
Jul 23 - PW results
Happy days coming I'd say!
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