Replies to post #3299 on Biotech Values

[DewDiligence]

>> Phase II Study with Visudyne
Anyone care to speculate when GENR will initiate the last of the Phase II studies? <<

The Visudyne combo study is less important than the “all comers” monotherapy study, and hence GENR may be reluctant to start the latter until the former is well underway, so as not to detract from enrollment in the mono trial.

The aggregate amount of drug GENR has produced to date could also be an issue in the timing of this trial.

In other words, I have no idea when the Visudyne combo study will commence. I am not unduly concerned, however, because modest slowness in enrolling the phase-2 combo study is not apt to delay the start of the all-important phase-3 trials. If months and months go by without the phase-2 combo study getting underway, then I would worry, but not now. Regards, Dew

[DewDiligence]

Re: Phase-2 Squalamine study with Visudyne:

Here’s an update on the comments in #3301 (#msg-3879254), which are shown in italics:

The Visudyne combo study is less important than the “all comers” monotherapy study, and hence GENR may be reluctant to start the latter until the former is well underway, so as not to detract from enrollment in the mono trial.

Still true, but…

The aggregate amount of drug GENR has produced to date could also be an issue in the timing of this trial.

I now think that drug supply is an issue for GENR. There is no other plausible explanation for such a long delay from the FDA’s acceptance of the IND until the commencement of all the phase-2 trials.

I am not unduly concerned, however, because modest slowness in enrolling the phase-2 combo study is not apt to delay the start of the all-important phase-3 trials. If months and months go by without the phase-2 combo study getting underway, then I would worry…

It has now been six months since the FDA’s acceptance of GENR’s IND, and I am officially concerned.