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leoncio1

12/31/10 11:52 AM

#8568 RE: UpstateChris #8567

the pp range from now till all is accepted could be:

$2.60 >>> $20 >> $40 >> $80 ???????

the question is when to buy,.. (now or later) If all gets green and accepted in the near future..

I bought a lot @1.90 and hold them long..

Succes,..

Grtz.. leon

mqwlaser

12/31/10 12:20 PM

#8571 RE: UpstateChris #8567

Chris,

You confirm with the company if you wish. I have been posting about my conversation with Culley since June of this year. They have not begun to produce commercial quantities of 514 at their intended commercial mfg. It is from this that the collection of stability data derives.

They don't even know if 514 needs to be retested or reformulated( if it is a go at all with the current data). That is the purpose of the requested meeting.

My understanding is that the FDA has 60 days after the request to SET a meeting date, not actually meet. When it comes it comes. But only if the FDA signs off on the CURRENT data will the company begin stability testing and commercial batch production at its icm.

That is why best case for an NDA in 514 is Spring 2012. If the FDA needs additional trials, add more time for that.

Hope this clears it up for you.

Good luck to all longs

Laser