Chris,
I would like like to add my thanks for your informative post. I have several comments/questions for anyone on the PRLN thread...
(1) What did they say about a new CEO? Is this "MD to spearhead the AndroVir rollout" going to be the new CEO? If not, then what position?
(2) AndroVir will have a PR campaign next month, ad campain in April, and introduced in May. It seems this is behind schedule, since last time they said March for AndroVir rollout.
(3) Given point (2), when will AndroCAr get rolled out? Did they say. A few months isn't a big deal I guess, but I'm just wondering what the delay is. The sooner their products hit the shelves, the sooner income is generated. Of course, it may take time to do this properly...
(4) You said "PRLN is precluded from filing an IND...". I'm confused. For AndroVir (a.k.a. PN355,1), PRLN has indeed filed an IND since they have completed a Phase I clinial study. IND is an "investiagtional new drug" report will you must petition the FDA for in order to start testing a new drug entity. For PN27,1 (a.k.a. AdroCar) they have not filed an IND, since their trial was "compassionate use" and not Phase I. Maybe they said "precluded from filing an NDA..." or new drug application which represents the final approval process.
(5) Did they say anything about East West's drfugs in clinical trials and will they continue the trials if they buy East West.
(6) 370 other potential drug? PRLN seems to have a bonanza here. Given their limited resources, have they considered liscening any of these compounds out to other biotechs/pharmaceutical companies for development? Even large companies do this when they have more prospects than they can handle.
(7) Did Koch mention anything about quality control? One concern I bave about the "dietary supplement" route is that the FDA is not overseeing their production and forcing them to ensure the purity and quality of the product. How will they test and make sure that the plant at Emerville is making AndroX properly?
I will probably have more comments later as I keep digesting all these posts...
Rick C |
