After the CC, enrollment is still my biggest concern. CYDY’s goals of enrolling 63 patients in 4-6 weeks and fully enrolling the trial by the end of the year seem lofty considering past enrollment. NP stated that Amarex is great at enrolling but enrollment has been very slow since late August, possibly even before that. NP stated that they believe they can speed the enrollment up to meet their goals and will send Amarex reps to certain enrollment sites to assist, and I hope he’s right and that they put effort towards the goals.. But why hasn’t Amarex being doing this in the past? The U.K. sites sound like they may be up and running soon, but I don’t trust the 7-10 day quote given by NP, so 2-4 weeks is more likely. Also, like NP and SK said on the CC, remdesevir and other BP trials will be competing for patients. NP and SK are hopeful the DSMC’s recommendation to continue the trial will help increase enrollment as well. We’ll see if that’s a contributing factor or not.
IMO, it appears NP is trying to get the interim analysis completed and returned by the end of the year, before the large payment is due to Samsung. His hope is that the trial will be halted at that time and will increase the SP, so funds can be raised and uplsiting can take place. I believe it’s likely we’ll see a few small raises in the near future to cover short term costs but only a large raise if enrollment is still slow. I think it’s a fair strategy by NP but he has to put serious funds and efforts towards enrolling in order to overcome competition from BP.
NP said he’ll provide bimonthly (or so) updates ok enrollment so we should have an idea of enrollment has increased during the 1st week of November.