The biggest issue with the S/C trial is enrollment
Post# of 154829
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Posted On: 10/20/2020 9:48:18 AM
Re: generactor #62095
The biggest issue with the S/C trial is enrollment. We’ve talked about this over the weekend and blafarm made a good post outlining the enrollment speed over the past couple of months.
The PR said the S/C trial currently has 230 patients enrolled, up from 221 on October 7th when Dr. STJ gave an update. That’s 9 patients over a 13 day period. That’s .69 patients per day. Blafarm calculated an enrollment speed of .60 between August 25th and October 7th, so the speed has increased by .09 patients per day.
At a speed of .69 patients per day, 91 days (mid/end of January 2021) are needed to enroll the additional 63 patients for the interim analysis at 293 patients. CYDY stated in the PR that they would like to reach 293 patients in 4-6 weeks, which would require an enrollment rate of nearly 2 patients per day.
At a speed of enrollment of .69 patients per day, 231 days (June 2021) are needed to enroll the 160 patients to meet full enrollment of 290. CYDY said in the PR that they’d like to fully enroll the S/C trial by the end of the year, which would require an enrollment speed of 2.2 patients per day over the 72 days remaining in 2020.
These are lofty goals considering enrollment has never reached 2 per day, competition has increased for trials, and treatments such as Remdesevir and plasma are being pushed on patients. IMO, the majority of the CC today should outline how CYDY plans to speed up enrollment. They have $18 million in the bank and 75 million shares at their disposa and should use those assets to increase enrollment. There is no doubt another capital raise is in the near future as CYDY doesn’t have the cash to survive past the end of the year.
Bottom line: Enrollment. Enrollment. Enrollment.
The PR said the S/C trial currently has 230 patients enrolled, up from 221 on October 7th when Dr. STJ gave an update. That’s 9 patients over a 13 day period. That’s .69 patients per day. Blafarm calculated an enrollment speed of .60 between August 25th and October 7th, so the speed has increased by .09 patients per day.
At a speed of .69 patients per day, 91 days (mid/end of January 2021) are needed to enroll the additional 63 patients for the interim analysis at 293 patients. CYDY stated in the PR that they would like to reach 293 patients in 4-6 weeks, which would require an enrollment rate of nearly 2 patients per day.
At a speed of enrollment of .69 patients per day, 231 days (June 2021) are needed to enroll the 160 patients to meet full enrollment of 290. CYDY said in the PR that they’d like to fully enroll the S/C trial by the end of the year, which would require an enrollment speed of 2.2 patients per day over the 72 days remaining in 2020.
These are lofty goals considering enrollment has never reached 2 per day, competition has increased for trials, and treatments such as Remdesevir and plasma are being pushed on patients. IMO, the majority of the CC today should outline how CYDY plans to speed up enrollment. They have $18 million in the bank and 75 million shares at their disposa and should use those assets to increase enrollment. There is no doubt another capital raise is in the near future as CYDY doesn’t have the cash to survive past the end of the year.
Bottom line: Enrollment. Enrollment. Enrollment.
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