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The home trial of completed 100 patients is being forgotten. If that is significantly positive FDA may consider EUA along with the UK phase2 inhospital study and phase 2 of active 2 data. FDA are keen for a safe (already proven beyond doubt) and reasonably effective treatment unlike MHRA and Bojo cronies
Denny11.. still need to be catious after a ao called 'gold standard' of double blind trials. A recent study found only 15% of US based clinical trials could be replicated (source pubmed) and ofc theres Dr. Goldacres expose about the murky world of clinical trial data ( search for his Ted talk in youtube "what doctors don't know about the drugs they prescribe " ....
So in brief, we know the following: a) 1st patient dosed on 10 Feb. b) 28 days after all phase2 patients (approx 110) have been dosed for final decision on continuation to phase 3 => No earlier than 10 March based on (a) above. Possibly 1-3 weeks after, depending on recruitment rate. We had a 1-week advantage over the other Activ participants. c) Synairgen will know results but cannot release any info as per design of Activ trials. d) Patients dosed earlier on may already have been moved onto Phase 3 even before decision has been made to progress to phase 3.
Basically, news blackout until Activ are ready to announce?
Great find of the activ2 pdf. Looks like they have plenty of flexibility in this trial. Also interesting info on page 23. 'Other: The TOC may also consider other secondary outcomes (such as the dynamics of virologic measures and symptoms over time, or any evidence of viral rebound to suggest resistance) in the decision to graduate an investigational agent from phase II to phase III evaluation, as provided by the DSMB. In addition, based on TOC recommendations from review of existing data from outside of the study, an investigational agent may move directly into phase III evaluation without completing phase II evaluation through this trial. Since this study has a transition between phase II and phase III evaluations, participants will be randomized into the phase III portion of the trial when the phase II portion has been fully enrolled, provided that an interim analysis when 50% of participants have day 14 evaluations shows that at least one of the graduation criteria has been met at that point; otherwise, enrollment will be paused. The final decision to graduate an investigational agent to phase III will be determined when day 28 evaluations have been completed for all phase II participants. This means that some participants may be enrolled into phase III evaluations before all evaluations have been completed in all participants in phase II, and thus, participants may be enrolled in phase III before a decision has been made by the TOC that an agent should graduate to phase III. '
Page 12: ‘Determination of whether a phase II agent will continue to be evaluated in phase III will be made after the last participant randomized to that agent or placebo group completes their day 28 phase II visit.’
Page 13: ‘Approximately 110 participants per investigational agent (and 110 on placebo) in the phase II evaluation and 1000 participants per investigational agent (and 1000 on placebo), including the 110 from phase II, in the phase III evaluation.’
Page 21: ‘Unblinded trial data will be provided to the Data and Safety Monitoring Board (DSMB) for interim analyses. 2. Unblinded trial data will also be provided to the DSMB after Day 28 data have been generated for it to assess Phase II graduation rules. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent. The small company group will not be allowed to share unblinded trial data outside of their group, per a clinical trial agreement. The rationale for sharing unblinded trial data to the small company group is to assist the company in deciding if their investigational agent should move into phase III evaluation or choosing a dose of their investigational agent to move into phase III.’
I was wondering whether we know for sure that they can be looking at the results "secretly" even while the trial in in progress despite it being double blind etc. Double blind is the patient and the doctor/researcher not knowing who got what.
Then I stumbled across a link which says in a triple blind trial "the people carrying out the statistical analysis do not know which treatment patients had." (https://www.nice.org.uk/glossary?letter=b) so I suppose it is possible in a double blinded they are getting results while the test is still in progress.
Org- there are no numbers on patients. They will conduct a review of all data and all patients doses so far, Phase 2 is purely to determine safety. It will also give indications wether the treatment is worth pursuing. It’s P3 that dives into efficacy and will recruit up to 600 more patients I believe.
Remember that we know SNG001 was the only one of the four 'new' drugs that was actually ready in time. The others lagged behind at least a week, so we had a free run at every new case. Given this and the number of cases were seeing in the US, it wouldn't surprise me if Activ-2 was filled within a couple of weeks.
Activ2 has a data and safety monitoring committee that has ongoing access to the data so they don't have to wait 28 days. If the data looks good they can enable the move seemlessly to PIII once PII has filled. Assuming the data is good, there will be no break or wait. From 10th March, Synairgen will then start getting a regular updates on patient data from Activ2. They can then use this data to update the various drug authorisation authorities...
Matt, you are bang on, and the fuse is already let for take off. I'm kicking myself as I sold most of my SNG to invest in Pearson Group which is going to take off. I was hoping that SNG would wait for me to raise more capital in a couple of weeks, but I fear i've missed the boat.