This delay shouldn't (IMO) take too long to resolve. There are TONS of contract drug manufacturers in the US that are GMP certified, and all in FDA compliance.
second, there are only 75 pts in the trial..and 1/3rd of them are placebo. And the pts on it get maybe 6 doses or so? So how much TB 4 is really needed????? ANSWER????? NOT MUCH!
So? Find another synthetic peptide contract manufacturer that has all blessings from FDA already.
However? if Finkle Boob insists on using whatever place that was NOT in FDA blessings....it make take a VERY long time to get that facility in GMP compliance. The FDA is slow as molasses I think in re-approving places. the paperwork I bet is massive.
As I said earlier???? Sigma Tau for MANY years was the contract manufacturer of TA-1 for SCLN. TA-1 is a similar synthetic peptide. Sigma Tau is GMP certified.
So duhhhh? if Sigma Tau can make TB 4 and Sigma Tau owns almopst 40% of RGN....isn't Sigma Tau a go-to place to call?
According to Fink's last presentation, rgn uses 3 diferrent contract manufacturers; one for topical form, one for eye drop, and another for the heart application. Why not just switch to one of the others. Dont know if that is possible but certainly one of the ones you mentioned could proceed quickly if these other 2 rgn uses couldnt. Bottom line here is that the hold hasnt hurt stock price any, which tells me stock is way oversold and a resolution of this problem would give us a little uptick from here. But, Finkelstein must act now and give shareholders an update now. NOt being proactive is not an option. Why cant we get rid of this bum?
because Finklestein married into Dr. Goldsteins family. That is the biggest reason.
second, is that our Board really isn't that "independant". It is controlled by......Finklestein and Goldstein.
if there was one OUNCE of "independance' Finklestein woudl never....EVER.get a raise or bonus..until he puts somethong on teh table winning.
Right now all we shareholders do is put almost $325,000 $400,000 in total compensation to Finklestein.....for nothing......except if you wish to reward.... losses, massive dilution....delays...very badly designed prevoius trials...and an excuse a minute from Finklestein.
Goldstein is complicit as well. He sucks out a $150,000 "fee" from us shareholders, even though he was highly paid over at his full time job at George Washington University.
Joe McNay somehow let his guard down, which makes him guilty as well of negligence.