I would propose that one of the lessons learned is to have an effective PR Strategy!!
Folks tend to forget that a Phase I trial is to ESTABLISH safety and the dosages are LOW!!!!
In GERN's case, the spin doctors were proposing that results would be seen in as little as 7 days, then a month, then two months. Well, it has been about 4 1/2 months and NO significant results have been reported.
Is this BAD???
I would say NO!!! The dosage could have been so low that no significant results were seen.
On the other hand, no bad results have occurred or the FDA would have entered the trial!
I would suggest that ACTC PR keep reminding investors of the purpose of a Phase I trial and minimumize undue speculation.
Why would it be bad to make sure investors and the general public understands (those invested should already understand) P1 is for safety. Although it is hoped that in the P1 gern trial (by gern), patients might have some type of positive results (and they may well have). It was stated that gern hopes to see some return of bladder control-a toe wiggle-ect...
In our P1 trial, (which is for safety as far as the fda is concerned). But unlike any/most drug trials ever done, we will be able to look right at these rpe cells, watch them and will be able to see what they are up to........Even if it is just a few (for safety)...are they doing what is hoped? Are they doing what the did in the animal studies? I look forward to hearing about it........