Biotech Values

[DewDiligence]

Size of phase-3 Squalamine trials:

[In reply to Yahoo #42562 by rstor1]

>> …it will mean that the [Squalamine] PIII's will have to be quite large, to satisfy safety concerns. This translates into a larger financial risk for the potential partner, which decreases the up-front valuation of the deal for GENR. Perhaps that is at the heart of the negotiation stall. <<

Bob: I agree that Squalamine's phase-3 trial*s* will have to be large, but I do not think the trials will necessarily be larger than those for Macugen and Lucentis.

To a large degree, Squalamine’s phase-3 trial sizes will depend on how many arms are in each trial. This number could be anywhere in the 2-6 range.

Particularly if the number of arms per trial is in the higher end of the above range, the total number of patients will need to be quite large to provide the requisite “power” to achieve statistical endpoints. Such a large number of patients would likely be sufficient to establish Squalamine’s safety profile, and hence I do not see safety as the overriding factor is determining the size of these phase-3 trials.