While I agree with basically all of your points below Medchem, I disagree with point 5) on searching for a signal to improve statistical power (data mining).
There is a good chance Ifenprodil does have an impact. My main reason's are:
1) More patients were most likely added to the non-treatment arm of the study receiving standard of care only. Patients could drop participation if they knew they were not receiving the drug being trialed. I need to double check this point because I do not remember in the news release if they stated which treatment arm the patients were added to. However, more patients in the non-treatment arm does also count as searching for a signal if they were trying to differentiate Ifenprodil's effects from standard of care.
2) You are assuming they have looked at the data and decided to add more patients to search for a signal. We don't know if this is true or not. I can see your thought process on jumping to this conclusion based on all the questionable decisions made and the quality of news releases. But as a statistician putting together interim data, I would hope they themselves understand to avoid data mining to satisfy the client.
3) This is perhaps my biggest reason on why I believe Ifenprodil can still have an impact moving into a Phase 3 study. Dosage.
Ifenprofil is known to be safe drug, but at what dose will it show an improvement in clinical symptoms? Do we declare the science a failure because we didn't give enough of the drug??? The dose makes the poison AND treatment. Did Algernon's high-treatment arm reach a blood plasma level to produce a minimum effective concentration???. We won't know until final data is revealed.
What we do know from their interim data was they saw a positive trend in the 40mg arm. It is my believe and opinion that 40mg is close, but not at the minimum effective concentration to have a noticeable effect on patients by day 15 of treatment.
If I recall correctly, the FDA provided Algernon with guidance and suggested a higher dosage arm of Ifenprodil before the study even began. If there is potentially a signal forming at 40mg, then Algernon might be able to increase to perhaps a 60mg dosage to verify clinical efficacy. The drug is safe and if there is data to support a potential higher dose, it should be investigated in my opinion.
-Ko
