Wow, I'm flattered you think I have so much influence over the market. I seriously doubt the market takes me any more seriously than you do. Just my opinion is that it will hit $6.90 well before it hits, LOL 45. The fact is that in spite of all the cheerleading on this board for this stock. It continues to drift lower. it doesn't matter if all of us cheer like Agnew. The market doesn't care what any of us say. least of all Agnew. As we speak $7.08 down another 7 cents. The rest of the market is not nearly as impressed with AMPE as this board is and that is the fact of the matter. reality doesn't take a holiday because you don't like it. $6.90 is just my tenative personal target for buying back in assuming I can close out some other positions and redeploy my some of my cash
reviewer, the more shorts on AMPE, the better! When this stock starts to go, it will be like a rubber band in the evening!!!!!! Most undervalued stock in the market. Any bank coverage, any deal with big pharma., Any approval and the shorts will be scrambling like I was to get away from my X!!!!!!!!!
Sentiment: Strong Buy
Imprv , the short tout a/k/a the folksy yakker is back. Tell us again what interest you have in talking the stock down to 6.90 (versus the lower prices you used to tout)?
Low life scammer and fraud artist: When the market discounts the FDA issuance of the BLA for Ampion which the breakthrough designation and professional publication which make all the more likely, your masters, until they cover, will be saying hello to huge losses. You have no credibility to lose only your masters money so you'll be saying on to the next one.
Agnew, seriously "i HAVE A TINGLING FEELING," now there's a stock metric I haven't heard before.LOL. Have to take note of that one, $7.11 down .05 as I speak. RAC is right about one thing it is getting close to a buying opportunity another 21 cents to go
" when the designation is granted?"
I'll go buy a beer for the leprechaun on the winged pegasus....
"low life scammer "
I assume once this pile of turd crashes you'll be saying "guy I should listened to......"
"With three blockbuster drugs lined up for quick FDA approvals (much less than one year)", can't even make that up
As others have said... great post billwilliams. To me the big issue is whether the FDA will consider OAK as a "serious" condition. I'm sure if they had it, they would, but compared to many other life-threatenening conditions it may not be. If they fail to consider it a "serious" condition, Ampion may still meet an unmet medical need, and may still be a substantially better therapy, and may still be a significant improvement. There should be caution in hanging one#$%$ on the "serious" condition label for OAK. It may not get it, but that would in no way effect the impact and ultimate value of Ampion and the company.
What will you do you low life scammer when the designation is granted? Apologize, disappear? Unfortunately not, you will concoct some other insignificant issue to rant about. Unless of course your employers, the shorts,use this weakness to cover or are squeezed into covering and your pay stops.
Yahoo gremlins deleted previous response, so once again...
A search on this board will give details about this. There are several knowledgeable comments. We just do not know if they made any application for accelerated/priority status.
Reports by Emerging Growth Equities state that the company may (or be expected to) seek breakthrough therapy status for K-L 4 patients. The FDA suggests application no later than Phase 2 for this. That would correspond to the end of the Phase III run-in trial (see March 2013 8K). So it may have occurred at the pre-BLA meeting. Fast Track is different and any application would also be before the pre-BLA meeting. "Serious" is subjective and determined by FDA. There is a 60-day response time for all of these.
Re-post of terminology (see FDA site for details)
FastTrack: no later than pre-BLA meeting
Breakthrough Therapy: ideally, no later than the end-of-Phase 2 meeting
Priority Review: with BLA
Expedited options, as listed on the FDA site:
Fast Track - fills unmet medical need (no other option) for a "serious" condition
Breakthrough Therapy - substantially better therapy option for a "serious" condition
Accelerated Approval - Fast Track using biomarkers and not clinical endpoints. Phase IV confirmatory trials needed.
Priority Review - significant improvement of a "serious" condition. FDA to act on application within 6 months (vs 10 for standard review)
Per regulation 21 CFR 312.47 (b) (2) Objectives of pre-BLA meetings include, as shown on slide #15 (see FDA site):
"Early discussions on priority or standard review, and need for Advisory Committee meetings"
"Breakthrough Therapy or Accelerated Approval designation. The FDA will rule on AMPE's application by sometime in January."
Really? Where did you get this from? I assume you'll apologize for being wrong when January is done and no announcement of either?
Almost as funny as Rich Cavalli claiming in June 2012 "With three blockbuster drugs lined up for quick FDA approvals (much less than one year)"
3 drugs by June 2013, fantastic!
You guys are funny.
You say Breakthrough Therapy or Accelerated Approval designation.If AMPE gets classified as a Breakthrough Therapy does that not also imply an Accelerated Approval designation? OR, can they get an Accelerated Approval and not a Breakthrough Therapy classification?