I have been told that when the application has been sent in there will be a press release stating so.
That will start the 60 day clock.
There will be that 30 (really 30-50) day waiting for the minutes after that. What happens at the next meeting?
Since it was the FDA that changed the target label to recurrent melanoma and made the treatable indication wider for more patients, then there is but no other answer I can see other than the FDA likes it, wants it, even said so, and wants more patients treated with it. To me the odds of approval would seem to be extremely high. Make your own mind up on that.
After the meeting? Its either an accelerated approval or short bridging study. What is a short bridging study? A short 1-3 month study to bridge the data from what they have to what they need to complete the required amount of data for the FDA statistical model. This is not a Phase III study.....I know this because I asked what a bridging study might look like.
And after that? New Drug Application filing (NDA). Well guess what? They have been doing a lot of that work already. Three big reproducible product runs at a cost of $1.2 million (per Mgt at two conferences)....Done!
Drug interaction study for the label.....that report just came out...done!
After the NDA?....a meeting here and there AS ITS GOING OUT THE DOOR.
After it's on the market then there will be a Phase IV study that lasts ten years to observe patients survival.
I do know that they have been working their butts off to get this application ready.
I think it will be announced soon.
vorlon, honey, I think you were a little bamboozled by some of Dees press releases.
The fact that the FDA accepts an application should never, ever be read as a sign that the FDA "wants" to approve a drug.
Next time, listen to Rosie.
Why are you told, why are you special, who are you?
The SEC should investigate you and your "special" relationship with PVCT.
Should not all shareholders get the same information at the same time?
Isn't that the law?
Do you have a closet full of expired snake oil?
Let's get real.
Why? This is common knowledge about a process. And they have investors relations you can call.
And who are you? What makes you a special troll that has been following this and providing inept comments on this company? Are you secretly covering to a long? You've been here long.
Are you really vorlon's alter ego? Balancing out what he knows with what little you know? Enjoying being the David to pv-10's Goliath? Only you're neither and just hanging out, trolling under a bridge.
Can you give us a riddle, at least, and allow us to cross the bridge? Lmao
I have called and spoken with members of Management, Investor Relations, Media Relations and the FDA when I had questions. Anyone who is serious about an investment should do their own homework and get all the information they can before going in. When one does this one does not get panicky or worried about the bumps and the noise. I have, what is for me, a significant holding in PVCT, and rely on my own research and education about the significance of this company and the drugs they are bringing to market. I know why I am so sure and focused on the success of this venture and do not feel that I owe an explanation to anyone about it. Get the information you need to make the decision for yourself and don't worry about the positive or negative statements of others.
You have the same chance to communicate with mgt as a shareholder
I have no sec worries
I don't trade the stock
I do have a position and I will sell at the end game
And I reported my conversation in this public forum
Is not that fair and helpful?
Many on this board talk to mgt from time to time
They don't always say so
You can communicate as well
Nothing is stopping you
Is my efforts annoying the short playing?
Didn't mean to step on your toes
I meant to stomp on them
one weakness in the pr that they were going to apply for the BTD, was sometime in the first quarter statement. this seemed a bit much. they should have been ready to submit. they had 30 days to start the writing of it, since they were in the meeting on dec 16. anyway, if they come out early this week with the pr they submitted, this would show strength to the process and end the downward pressure on stock price. end floundering. lets hope your rumor is correct.
When and if the "press release" comes out...all will know your laundry list is rolling. We'll soon see Vorlon. Until such time go enjoy your weekend. Your work is done here. Now the threads should be Broncos or Seahawks?