They will unblind the trial for an interim look, I'm guessing at halfway mark. The Phase III is enrolling 238 patients, and they have activated 8 trial sites, with the first patient dosed on or before May 6. The primary endpoint of the trial needs 28 days, and a few secondary endpoints need 60 days. The trial description states: "An interim analysis is planned for DSMB to assess safety & efficacy data."
28 days from May 6 is June 3. That is when the first patient will cross 28 days. Assuming they were able to enroll 5 patients per day during this time, that means 120 patients enrolled by May 29, with the final patient of the 120 passing 28 days on June 26. Those 120 will hit 60 days (and the complete end of the trial for the 120) on July 28.
I assume the following:
1. HGEN will do the interim analysis after half of the participants reach 28 days (the primary endpoint) rather than the full 60 days of the trial period, which includes some 60 day secondary endpoints. I think they will do the interim after 28 days because the DSMB will be looking at both safety and efficacy. For safety, they'll be wanting to know earlier rather than later.
2. HGEN was able to recruit 5 patients per day from among those 8 trial sites. I think that would be very achievable, especially more recently when cases have spiked and all sites came on line.
3. It will take 14 days for the trial sites to verify, sign-off on, and submit the data for the first 120 patients (which is July 10).
4. The DSMB will see the compiled data of the first 120 patients that have reached the first 28 day endpoint on July 10.
5. The DSMB will take 3 days to analyze the data and be able to present their analysis to HGEN on July 13.
My questions:
1. Will the DSMB reveal the details of the data to HGEN or simply tell them to continue the trial (or stop the trial because it shows statistically significant efficacy and safety)?
2. Will HGEN be required to reveal the interim data to the public as material news, or will they be able to hold it for further analysis? Material news must be shared within 5 days.
My speculation:
1. HGEN will want to uplist prior to the release of the interim data (if they must release interim data), so they will hold onto the info for as long as they can, because the odds are the data will be excellent and show efficacy and safety. They would much rather produce the data when they are on the NASDAQ, because it will broaden their shareholder base, allow for more institutional buyers, and more volume and attention.
2. HGEN is very near to uplisting, perhaps only 2 weeks away. The main remaining element is the Notice of Effectiveness of their registration statement for the recent $70 million offering. (File No. 333-239161).
3. HGEN will announce uplisting on July 20 and interim trial results on July 22, or if they must announce interim results, within 5 days of their receipt of the information, they will announce them on about July 15-18.
