phlucked for a while. Yeah, I bought a lot more and I'm sitting for now. But I have some issues. 1-It does seem as if that PR yesterday noted they ADDED the validation for MK recently, much to my chagrin, I was right, and that sucks. I was under the impression as was everybody that the facility was originally proposed to be validated for MK, so being it was just "expanded" to include it, SUCKS, IMO. 2-Dr. Pablo Romanus either exists or doesn't. IF the company were doing their completed DD, when that American Chronicle article came out someone over at CVM either knows him OR should have asked "who the phluck is Dr. Romanus". You either are agreeing with him by being silent or say something. 3-If Biomedreports knew about Dr. Romanus, THEY should have done DD as well. They still can and should, actually!!!!!
I think we're being hit from so many fronts that it's very difficult to focus on what's true, what's important and where it's from, etc No one is happy. But, as the Biomed article pointed out, they cannot control the editorial contact of what anyone writes. My point was if you "use" that then you MUST verify it. I'm buying under $1.35 again. And I'll sink OR swim, or fly.
cGMP manufacturing requires not just validation of the manufacturing site (water, equipment, sterility, etc) but THEN they have to make several batches of the drug in THAT facility to demonstrate that it can handle the task. You cannot move from making small amounts of a drug elsewhere and expect that the methods, reagents, sterility, potency, etc will necessarily be the same. Are any two identical cars made on two different assembly lines in different plants the same? Not necessarily. So they will most likely do several runs and look at the potency, the batch records, the sterility (bioburden), etc., etc and then they get the complete Drug Master File it approved. If done right it does not mean a big delay. They have to get the PIII enrolled and the protocol approved and these things can happen at the same time. By the way I do not know the exact make-up of MK or how they make it but if they are making large batches it means they have to work with specific vendors and suppliers to get what they need in far higher quantities then they have required before, right? So it all takes time which is just another reason why new drugs take so long to get to market.
All this will take is some positive news on any one of a number of fronts and away we go. This was only 14 cents in February so hang on.
Now we all know what Moscow Rules are. Trust no one. They played us, but we don't know who was playing? Meanwhile there's a lot of shares being bought/sold at $1.33. I'm still above water, way above and I'm gonna bottom feed, but I hope I'm bottom feeding on the bottom.
They have to clarify this statment about the facility. After completion of Phase II They announced they were getting their own facility to make Multikine so that they could go directly into manufactering once they are approved after phase III is completed. Latter on it discussed in releases that it will contract if for other companies use. I don't get it. As far as Dr. Romanus and Adam and TheSreet, I hope we get a pubic rebuttel statement today. Dr Romaus has a web page. http://www.linkedin.com/pub/pablo-romanus-m-d/16/347/346 Cel-sci is not under the radar anymore and needs to respond to these attacks immediately.