Biotech Values

[DewDiligence]

>>I think we can start by using macugen phase III as a reference point to what was expected for squal.<<

In phase 3, Macugen was tested on approximately 900 patients for two years. For Squalamine, I think the FDA will ask for 1,200 patients for two years (probably in dual trials with 600 Squalamine patients each).

If the above is correct, counting control arms the total number of patients to be enrolled is 1,500-1,800 depending on whether the randomization is 4:1, 3:1, or 2:1.

Your use of the word “presumably” is perfectly reasonable, by the way. It’s not an absolute given that enough patients will enroll in the main phase-2 study to get to phase 3 in a timely manner.