To clarify (although much of this has already been said, from the 8K): 1)the $4MM debenture due in three years can be converted to 40MM common shares at any time; 2)40MM warrants to purchase restricted common shares @ $0.15 have been issued which if exercised would bring PLC an additional $6MM; 3) the Investment LLC has agreed to a second $1MM tranche if PLC enrolls 25 patients in a US trial and generates $1MM in gross RG revenues. This is equivalent to a venture investment by the LLC (i.e. a cram down to existing investors). We should be glad because it means adverting bankruptcy and provides an institutional investor continually on the bid to drive up the price of PLC stock. This is essentially a laddering agreement that guarantees the investor that however much stock they purchase in the open market their cost average will always be much lower than the market stock price. The higer it goes the more the LLC makes (on paper) limited only by a coherent rationale for the market capitalization.
Clarification regarding the clinical trials: 1) the US FDA has no requirement that the trials be conducted in the USA (the only place that does is Japan who is generally a late adopted of drugs and medical devices - comapanies usually follow through because it is a goldmine if accepted because the practice of medicine there is based on writing lots of prescriptions and doing lots of clinical tests and they have an aging population); 2) data from the trials in Milan and Naples are sufficient to make application here, and in some ways better because the lead investigators in Italy are the world leaders and most of the MDs here are less recognized (and I believe some of the patients in the Naples trial are from U of Vermont); 3) the most important conclusion from the release of the preliminary results is that hydration = placebo; 4) yes, if the final results mirror those released an insurer would be liable for damages if they turn down paying for the procedure and it would be unethical for the docs not to perform RG if you are diabetic, elderly, or in some way have compromised renal function.
So, what is RG worth?? In my opinion, even at $3 a share it would still be 0.05-0.10 on the $ if successfully marketed. Much more if successfully marketed worldwide. Of course, current management has done little other than to run the company into the ground. One consequence of this finance is that if the intital debenture is converted the LLC assumes a controlling stake in PLC and can dump current management and an acquiesent board and replace them with people capable of generating results.
Nice post science. After reading about FDA approvals for medical devices it looks like we would have to apply for a 510K from the FDA and probably our device would fall under a class 3 device. Not sure how long all of this would take but I figure since management is under the gun and on a 2 to 3 year timeline that PLC figures that the process will be complete in that timeframe. I not sure if having the Mythos or Remidial 2 studies complete helps to speed up this process or how many patients would have to be tested. Hopefully management can shed some light on the timeframe and process at the next quarterly report.
Do you really want Marc and the boys sitting on their hands collecting paycheks for another three years while we stay in limbo.
I don't know how long it would take. Unlikely to get accelerated consideration at the FDA because they've had a few such approvals blow up in their faces. Maybe someone else could shed light on this (MT???? - Ha Ha Ha).
510K is generally a quicker approval path for devices that already have a substantial equivalent on the market. Since this is the first of it's kind, the process is known as PMA (Pre Market Approval). It is more stringent and requires clinical data.
"One consequence of this finance is that if the intital debenture is converted the LLC assumes a controlling stake in PLC and can dump current management and an acquiesent board and replace them with people capable of generating results."
I truly look forward to this day! I am really surprised that the new investor didn't at least get a couple of seats on the board.
Just a back of the envelope calculation to put this transaction into perspective: The funding essentially buys 2/3's of PLC for $6M.
If they would have just brought the company for $6M, that would be about $0.20 per share verses the current 0.12 price.
The RG product looks to be a great story with massive potential: the current management team - not so much. However, it looks to be a low risk entry point up to ~ 0.20
Would it not be correct to say that for the warrants to require cash payment PLC must have an effective registration statement for the shares. Is there any reason that PLC would *not* have such a registration statement? What difficulty would lie in their way to get that done?
As for there being no FDA requirement that the trials be carried out in the US: if that's correct, then why wouldn't PLC be in a position to simply present the finished Italian trials? Is it because they themselves didn't directly sponsor them? Otherwise, why would they need $Ms to conduct the trials in USA? Are you sure that you're correct in this?
Finally, what do you mean by "in my opinion, even at $3 a share it would still be 0.05-0.10 on the $ if successfully marketed. I don't understand what you're saying here.
Oh, also, how long have you been following this stock; if only recently, what caught your attention? If for a long time, then why have you not posted before--or have you under another name?
$4MM now. Additional $6MM if they decide to exercise their warrants (cash), I believe their good for three years.
Yes, I'm sure about the FDA. After two independent trials with hundreds of patients doing another trial with 25 or 50 patients isn't going to contribute much - it would be a waste of time and money to do it.
Had shares longer than you. Obviously it would have to go up quite a bit for me to break even.
There are a lot of details to conducting a study to support US registration. An investigator-sponsored trial not conducted with a view toward this goal is unlikely to be able to stand alone.
And as always, the initial success and subsequent failure of both NAC and overnight hydration make it imperative that a preventive measure against CIN have multiple independent confirmations of its effectiveness.