Alright folks lets do this.
Have you ever noticed your broker crying all the time? Has the decade-long battle with 10,000 DOW left you with Pseudobulbar Affect? If so I have the stock for you.
AVANIR! No not Avitar! AVNR.
This baby bio has combined two drugs and formulated a third. This is always suspect can't folks just mix up their own batches? yes and no. The fact is 1 mil folks have this uncontrollable laughter and or crying and only half of them are employed on wall street.
>Pseudobulbar affect (PBA) or labile affect or more informally emotional incontinence refers to a neurologic disorder characterized by involuntary crying or uncontrollable episodes of crying and/or laughing, or other emotional displays.
PBA occurs secondary to neurologic disease or brain injury. Patients may find themselves crying uncontrollably at something that is only moderately sad (NYG losing), being unable to stop themselves for several minutes. Episodes may also be mood-incongruent: a patient might laugh uncontrollably when angry or frustrated, for example any daytrader.
The AVNR story goes back to 20006 when they got fast tracked for Zenvia their treatment for PBA. The FDA rasied some concerns- this was based on the dose of Zenvia that contained 60mg of quinidine one of the two compounds that make up Zenvia. The original therepudic dose was closer to 30mg and this test screwed the co. At lower doses no bad side effects that would stop FDA approval were spotted.
Anyway skip forwards and a major new trial the new Zenvia would have 30mg of dextromethorphan and only 10mg of quinidine-- gone went any cardiac risk. Ok so the new trial of Zenvia 30/10 dose had almost a 47% reduction above and beyond placebo and the Zenvia 20/10 dose having almost a 50% incremental reduction above and beyond placebo with both achieving strong statistical significance.
By the 5th dosing, Zenvia treatment arm had an 88% reduction in episodes vs. baseline.
So what we have is a drug that's a shoe in. It's formed from two known compounds and it was getting the mix down that mattered. We have a production facility ready to roll that the company has contracted with big European one can't remember the name. They have 1200 or so resumes for a salesforce; all they need now is the FDA ok. And here in comes the timing-
Oct 30 action Date***** You get 55 business days beforehand when the FDA may request a special talk... that time passes as of today or tomorrow. So we have a straight on bet for Oct 30 a stock at $3.00. The market I see as big because many diseases jump into this PBA and there are some pain relief associated with Zevia which by the way cannot be called Zenvia! The FDA has told them that the first part " Zen " means well being and was too promotional... Well at least it shows the company is talking with the FDA all the time.
AVP-923 (temp name) will be priced at $3,000 to $5,000 a year with unlimited year over year use. the patent is very secure and long 15 years.
Co has $41 mil cash and a burn rate of $16 mil per 9 months
Well it's a bet on now till Oct 30 how high will Avanir climb in anticipation of approval? $5? Then what after $7 and $10.... that last one is Jeffries price target.
3,500 AVNR @ $3.10. ~stoney
Have you ever noticed your broker crying all the time? Has the decade-long battle with 10,000 DOW left you with Pseudobulbar Affect? If so I have the stock for you.
AVANIR! No not Avitar! AVNR.
This baby bio has combined two drugs and formulated a third. This is always suspect can't folks just mix up their own batches? yes and no. The fact is 1 mil folks have this uncontrollable laughter and or crying and only half of them are employed on wall street.
>Pseudobulbar affect (PBA) or labile affect or more informally emotional incontinence refers to a neurologic disorder characterized by involuntary crying or uncontrollable episodes of crying and/or laughing, or other emotional displays.
PBA occurs secondary to neurologic disease or brain injury. Patients may find themselves crying uncontrollably at something that is only moderately sad (NYG losing), being unable to stop themselves for several minutes. Episodes may also be mood-incongruent: a patient might laugh uncontrollably when angry or frustrated, for example any daytrader.
The AVNR story goes back to 20006 when they got fast tracked for Zenvia their treatment for PBA. The FDA rasied some concerns- this was based on the dose of Zenvia that contained 60mg of quinidine one of the two compounds that make up Zenvia. The original therepudic dose was closer to 30mg and this test screwed the co. At lower doses no bad side effects that would stop FDA approval were spotted.
Anyway skip forwards and a major new trial the new Zenvia would have 30mg of dextromethorphan and only 10mg of quinidine-- gone went any cardiac risk. Ok so the new trial of Zenvia 30/10 dose had almost a 47% reduction above and beyond placebo and the Zenvia 20/10 dose having almost a 50% incremental reduction above and beyond placebo with both achieving strong statistical significance.
By the 5th dosing, Zenvia treatment arm had an 88% reduction in episodes vs. baseline.
So what we have is a drug that's a shoe in. It's formed from two known compounds and it was getting the mix down that mattered. We have a production facility ready to roll that the company has contracted with big European one can't remember the name. They have 1200 or so resumes for a salesforce; all they need now is the FDA ok. And here in comes the timing-
Oct 30 action Date***** You get 55 business days beforehand when the FDA may request a special talk... that time passes as of today or tomorrow. So we have a straight on bet for Oct 30 a stock at $3.00. The market I see as big because many diseases jump into this PBA and there are some pain relief associated with Zevia which by the way cannot be called Zenvia! The FDA has told them that the first part " Zen " means well being and was too promotional... Well at least it shows the company is talking with the FDA all the time.
AVP-923 (temp name) will be priced at $3,000 to $5,000 a year with unlimited year over year use. the patent is very secure and long 15 years.
Co has $41 mil cash and a burn rate of $16 mil per 9 months
Well it's a bet on now till Oct 30 how high will Avanir climb in anticipation of approval? $5? Then what after $7 and $10.... that last one is Jeffries price target.
3,500 AVNR @ $3.10. ~stoney
~stoney