Congrats all! Wish they had waited a couple more days so I could move ACAD money back here, but I will take the win. Hopefully she doubles today.
Also should mention bear market is a blessing. If this thing was already at $50 I would say you are right, but its not so it has room to run.
Stock should still react on positive news. Can't think 4 steps down the road from a catalyst. Market certainly doesn't. People will jump in if they think the price can still go up from wherever it is and that they can sell before it goes down. Have to ask why it ever hit $50 with all the things you mentioned still being true back then. Don't know how much this will jump, but I am sure it will jump and $35 is a reasonable target. Momentum will be in play as well and that is when things can get very interesting.
As for risk - no way no how this vote is negative. Odds are better than 100 to 1
Hope you are wrong. Looking to make that money Wednesday and went in deeper following briefing docs. Approval looks obvious to me with the responder analysis the FDA did in Figure II and this stock was $40 not that long ago. GWPH jumped 100% on an "obvious" phase III success because of the derisked pipeline. Don't see why can't happen with another stock at near 2 year lows on an "obvious" approval.
Think some are still worried the FDA has a surprise about efficacy up its sleeve. I think they are just setting the standard for future drugs at the higher threshold of 50% improvement (which threshold ACAD passed with flying colors on the responder statistical analysis). The safety issue is a red herring to justify the analysis of clinical improvement.
Decided to enter this because of a post by you a few weeks ago. Hopefully decision to stay turns out to be correct. We will see if ADCOM approval still means something in this market.
Anyone have a good explanation for the surge? The market cap is way in excess of companies (like ours) that look to be in a much better position with their drug launches. They have 50M in cash, no sales force, resistance from docs bc of concerns about impact on lungs of inhaled (whether justified or not). Is there some catalyst that I am not aware of? What am I missing?
Makes absolutely no difference. Guy moved up in the world to the e-suite of another company and the sales machine is already set up to roll on auto-pilot. Also Kerx responded to my letter. Legal and marketing have been tracking the AMRN decision and settlement closely. Good to know.
Agreed. At the very least hope they can get more aggressive with the marketing of the iron implications without fear of a huge fine hanging over their heads.
I'm not an expert on what they can and cannot say regarding iron following the upcoming P3 data, but if the Company anticipates any continued limitations I think pre-emptive suit of FDA should be considered. I just sent a letter to investor relations to highlight the possibility. Hopefully they actually read letters from investors
I think it raises some very interesting marketing questions. FDA claims decision only applies to AMRN. Will require a few more companies to challenge FDA but also might make FDA rethink when it challenges companies regarding marketing. Advocating Iron benefit by our reps is currently not permitted. This opens the possibility of marketing iron benefit anyway and successfully giving the finger to the FDA.
Interesting NYT article where AMRN won lawsuit against FDA to allow promotion for off label use with truthful information. Judge determined FDA restrictions impaired the Company's free speech rights. This could get very interesting. FDA trying to hold the line for now, but an excellent precedent for companies like Kerx being able to promote outside approved patient population (specifically our iron benefit) without ridiculous FDA interference.