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Re: PJ007 post# 272956

Thursday, 09/19/2019 6:55:30 PM

Thursday, September 19, 2019 6:55:30 PM

Post# of 403044
"Usually a phase 3 can run from 300-3000 patients....The FDA is only asking for 300....that INDEED is a positive sign!!"

Probably depends on the condition being treated. I checked clinicaltrials site for ph3 OM studies and found the following 6 of the first 12 of 91 listed(stopped at 12).

1. Sun Yat-sen University in China. Drug-ulina statin. Projected enrollment 176. Start 1/30/18, est primary completion 12/31/19, est study completion 12/31/22. Estimated start to study completion ~ 3 years- 11 month

2. Soligenex. Drug-SGX942. Projected enrollment 190. Start 12/4/17, est primary completion 3/2020, est study completion 12/2020. Estimated start to study completion ~ 3 years

3. Galera. Drug-GC4419. Projected enrollment 335. Start 10/2018, est primary completion 10/2020, est study completion 10/2024. Note, last update 10/8/18. Estimated start to study completion ~ 6 years.

4. Novartis. Drug- Everolimus(OM for breast cancer patients. Projected enrollment 200. Start 3/26/15, est primary completion 3/31/19, est study completion 5/31/19. Last update 8/2/17. Estimated start to study completion ~ 3 years- 2 months.

5. Zhejiang General Hospital. Drug- Recombinant Human Interlukin-11. Projected enrollment 300. Start 11/11/18, est primary completion 8/31/21, est study completion 8/30/22. Estimated start to study completion ~ 3 years- 9 months.

300 patients seems around normal for ph3 OM study.


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