Biotech Values

[DewDiligence]

>> My question to you is, what will be your impression/recommendation/investment of GENR if it (or partner) does NOT seek and obtain Special Protocol Assessment as they further the trials with Squalamine? <<

An SPA is needed only for a pivotal trial –it is not needed for an intermediate-stage trial such as the one GENR says it will launch in the next few months.

If GENR, with or without a partner, were eventually to launch phase-3 trials without securing an SPA, I would be very skeptical and I would probably sell.

Fortunately, I think there is close to a zero chance of this happening. From here on, I think the only companies which do not secure an SPA for pivotal trials will be those whose management is negligent or corrupt.

PARS launched its pivotal trial before the SPA concept was as firmly entrenched as it is today, so the lack of an SPA in their case is not necessarily damning. However, I believe PARS’ lack of an SPA does increase the risk to shareholders to a pretty significant degree.