Yep they thought the NDA was ready to go (the paper work has been completed for a long time), but Uli's time line was all wrong. He thought they could use the manufactures they were already using in their present state. He didn't have a clue of the time it would take to prepare the Manufacturing QA. He probably thought he could focus on the manufacturing QA while the FDA took its 60 d to accept the NDA. He pressured Davis and Mills to say " still on track ", but then the BOD figured out (told by Davis, Mills or some consultant) they needed a delay. That put ACAD at risk for a legal action. So Adios Uli, enter the new interim CEO Davis ( and Mills) both plead ignorance. If they knew they are both liars and if they didn't know they are both inept as far as leadership goes. Either way Davis should never become CEO.
shorts are already chatting it up for tomorrow, their plan is to let it move up then short it down. You might have an opportunity tomorrow, maybe even the next day. Be patient at this point to get a good entry point. Guessing it will go to the $2-$3 range. GL
Heard it works...heard it doesn't....but lets just say it won't hurt...unless they get bought out for $25. ;)
I mean look at ACAD ( Pima for Parkinson's Disease Psychosis), ITCI (ITI-007 for Schizophrenia) with a single drug that will make about 1Billion+ in Rev once approved. They are P3's yes, but the sp range is from $28-about $48. Think about it, AVXL will have a way larger patient base than any of those companies.
Well anyone using a SELL STOP will lose their shares. You might as well just sell outright if you are going to give a heads up to the Market Maker and get stopped out at a lower price. Dumbest thing you can do is tell the MM to sell your shares, he/she will not even say thank you when they pick your pocket.
Yep, its a small study so far. OK so throw out all the measurements...the thing that caught my eye was this....." “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
Now I use to prescribe Aricept to patients and I can honestly say over 50% of my patients said it didn't do much, but they kept on using it for the most part...why? because it was cheap and gave them hope. Here we have the patients asking please let us keep taking it. To me that is one result that is hard to measure, but shows the data is making a difference to those patients. If you think this is too risky, short it, sell it, or move on.
An estimated 5.3 million Americans of all ages have Alzheimer's disease in 2015. There is no cure. "In the U.S. Food and Drug Administration (FDA) has approved two types of medications — cholinesterase inhibitors (Aricept, Exelon, Razadyne) and memantine (Namenda) — to treat the cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning) of Alzheimer's disease."
Aricept is least expensive about $12/month generic. Namenda is about $4200/ year ( about $350/mo). I am thinking a new "better " drug will cost about $6000/yr. So with 10% penetration = 530,000 patients, would bring in about 3.18 Billion/yr in the USA ONLY. There are about 35 million AD patients world wide. ...
Cramer pounding the table for a small biotech....he rarely if ever makes a call on stocks in small MK/biotech. Could be AF really likes it, or several "Cramer friendly " hedge funds bought into the offering.
Shorts always jump on new highs...not a surprise and their buddies like AF always help them out. I use their garbage articles as a buying op. Keep some dry powder for those times.
The reason I mention this is it occurs so often when stocks breakout. Look at EXEL, But as bad as dilution sounds, for this company it would be well worth it. As companies grow, so goes the burn rate. I would think their burn rate will now go up. new hires, consultants, energized to move and expand some of their studies forward etc. I'am thinking they will now pay bigger bonus money and larger options too. That all adds up fast. Most likely they will put out some new shares , say 5-10 mil shares discounted to the Big firms, hedgy's etc. Probably under $1 ( current price $1.09). At this time they are hoping the stock moves higher so they can price them higher. So don't be surprised if you see " other events " hit the screen. For EXEL, the down turn only lasted a week or so. I would buy big on any dilution sp drop.
Sorry, new here, explain "cashed up". Stats show they only have like 6+Mil.