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where is newsmixers' countdown to GMP? Oh, that's right. It's at 0.
I can't wait for this pps to blow up on news about when trials will begin. That's the news that I think sends this high without looking back.
They have said Q3 of 2015, which means July 1st - September 30th. There was no mentioning of PMCB's 3rd quarter.
If it were only that easy. We will still want to see these preclinical results (most recent).
We'll have to wait and see. It is a bit strange that they're pressing on old studies if the new ones are going very well. It does some like an attempt to get the stock price up in the short term.
I'm not losing confidence here but I'd be interested as to why they would lean on olds news. Some what of a red flag to me. Hopefully the results from the study come out soon.
Last time I looked at the calendar May had days left and June hasn't started....
I would love to know how you think promising something that is completely out of your hands is a good idea. The date for approval is out of their hands! Things take months to review in this sector! PMCB isn't going to lose their credibility over a projected approval date in which they have no control over! They're simply giving us an estimated date so we know an approximate timeline for trials to begin.
Please, please explain to me why this isn't the honest and SMART way to handle things.
Also, please show me a PR where major pharma promises investors something that is out of their hands!
Yes, that was me who posted. If anybody has updates on this, that would be great. I know somebody mentioned something about what PMCB must present next, but it wasn't 100% clear.
Thanks!
any idea where things stand with the EMA application/follow-up and what information we are required to submit next?
I know we withdrew because they wanted to see more info but haven't read much since.
hey, can you post link to this? I've been trying to research where things stand with PMCB and EMA. THANKS!
Yeah, you're right. One of the premier doctors working on pancreatic doesn't care about who he associates himself with. He just takes any work he can get at this point. Who cares about credibility and reputation? He has nothing to lose....you're right!
I love how people think it's easy to predict when trials will start a year in advance. Clearly uneducated.
If you look at the minutes you can basically figure out its them based on mentioning of encapsulation. Either way, this is very typical and they are generally tighter than FDA. I'm not worried a bit. They can resubmit with new trial data.
Could you be any more less specific?
It's pretty clear what they have going on haha.
Finally somebody puts it all out there in simple, easy to read language.
And actual factual information!
It's all relevant. Pete, why are you doubting 2b?
There's absolutely no reason to. It's still our bread and butter right now.
I'm not worried. It's clear from the minutes that they want more data, which just means they're tighter. We can reapply with additional data from next trials.
No worries at all. Everybody do their DD. Long and strongggggg
If you go back in the minutes and reports from previous notes, you can make the assumption that they are 178/14.
Can we find out what pharmacytes number is or is that confidential?
I'm long, but you're right. I found the same as well this morning.
Bud, relax. It's clearly not a scam. It's a penny stock that is volatile. It's a bad day of trading.
Do your DD.
The patent for the nano system was just issued in September of 2014. Cell in a box received worldwide rights in 2013.
Pharmacyte is going into IIb trials while many of rexahns are phase I, with the furthest in IIa (archexin). Where do you see they are further ahead?
They have much different things in the works as well.
Yes please so we can invest haha
You continue to press on the O/S but don't seem to have anything else to say....
Can you enlighten us on why a company that just received orphan designation through the FDA, with Europe and Australia pending; as well as exciting diabetes stuff in the works and more, should worry us?
http://www.nanomedicine.com/Papers/JNNPharm06.pdf
8 years ago but good read!
that is completely false...it is PHCB
Smart move to give themselves a clear identity...if you know business, then you know why they did this...
In other news, the EMA COMP meeting kicked off today and will run until the 9th. Treatment for pancreatic cancer in on the agenda for orphan designation discussion. I WONDER WHO THAT COULD BE?!?
I won't complain about 500 mil when billions are rolling in....
Where do you see a new website? It's looked like that for months.
That's mostly just speculation at this point but a definite possibility as we move forward.
This platform has endless possibilities for licensing if these trials produce positive results again. What Nuvilex decided to do with that is unknown but we're talking billions if things go well.
Wait. so let me know get this straight....
so you think there's actually possibility the FDA is in on this?
This will be manipulated until market approval, which is fine for the longs.
EMA Website shows "treatment for pancreatic cancer" on January Agenda!!! Must be Nuvilex!
http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2014/12/WC500179564.pdf
That's marketing approval. Completely different. Once trials show positive results they can market and sell the drug. That's the next step.
Just picked up a modest 6k shares more. This should be a nice few months ahead. Positive results for trials in the new year would be awesome.
Do you have a link to the FDA portion of the website that says this.....
Or is this all speculation from a stupid benzinga article
Are you guys kidding me? There's nothing new that has been reported. Why are you all freaking out?
Exactly. They could have possibly made a decision earlier but the projected date of a decision is at the Jan 7-9 meetings. Just another person jumping the gun.
Sorry shorts. You will have to wait a little longer. Us longs are fine with that.
Correct. You can find the chart on the EMA website. Review should be at the January 7-9 meeting based on nuvilex submission date of September 2nd.