To ignore the hype of posters here when this stock traded in the high $3's. I advised waiting for sub $2.50 levels and to wait for dilution. Both have occurred and I recommend you purchase this stock in the trading range of $2.45-2.65. This stock will get traction and should trade to the $4.75 to $5.25 level as it runs up in anticipation of the PDUFA date of 10/11. Good luck all.
I thought the opposite, that Moretti WAS confident that Alexza could use the technology to keep the patient from overdosing (for AZ-007). That was one of the advantages he said for doing Staccato Zaleplon. The Staccato device itself will keep patients from overdosing. The device they would use for Staccato Zaleplon will have an electronic lockout feature and a patient ID feature. The lockout feature will keep patients from using the device more than once during a set period of time and the ID will ensure that only the patient will be able to use the device.
As for the medically surprised restriction for AZ-004, that's only because all clinical work was done in a medical supervised environment. It doesn't mean AZ-004 can't be used away from the hospital safely. It just meant Alexza doesn't have any info/data one way or the other to give to the FDA yet.
Alexza would need to do an additional followup safety study later for an outpatient setting to get rid of that restriction (which they've already have planned for). And it is possible that the FDA will approve the drug without any setting restriction at all (possible, although the restriction is the most likely outcome initially).
One of the future milestones payments from the Biovail deal is AZ-004 approval in an outpatient setting. So Alexza already has plans for this.
(Please excuse any grammar/spelling mistakes. It is late and too tired to edit myself. haha)
How did you arrive at your price targets? I looked at ALXA at $2.60 and $2.80 based on my conversations with an employee, and looked at it at $3, before the dilution. I bought in that day around $2.50 several times, before doing full due diligence. I like what I see--the lower-risk path of faster delivery into the system with an already FDA-approved drug. But how did you come up with the price target? Based on market size, penetration, replacement of existing treatments?
Also, does that pps factor in other drugs in the pipeline, or only PDUFA on October 11? Thanks in advance for your response.
Dakyne: My valuation of ALXA is a combination of sales projections of Staccato Loxapine and a statistical model of my own based on many years of data collection on stocks with upcoming PDUFA events. Alexza has potential revenue at maturity of sales of Loxapine estimated at $300-500 million annually (Biovail Parnership). I factor that the market may accept 30 - 40% of that as a reasonable multiple in a valuation model for a company with a drug up for approval. In this case if you consider Alexza will take in $150-175 million dollars near term I would conservatively place a value of shares at $4-4.50 per share. I believe investors will bid that up a bit on approval expectations. This is where I allow my statistical model to refine my calculation. The statistical model I use places the predicted value of the run-up in the $5-5.35 range. I scale that back a bit and compare to the valuation model I came up with. I try to be conservative. It will likely take quite a few years for ALXA to achieve the $300-500 million level. The market will be slow to recognize that potential.
So, in very simple terms that is where I get my valuation. At some point it may be valued at $12 per share as some analysts reflect. That is a ways down the road. They are early in the process with other products. I don't consider them at the moment.
Is the partnership with Biovail only for the lead candidate AZ-004, and Alexza retains full marketing rights to all the other applications? Any other current partners? Thank you in advance.
Ram u got the 1st part of the prediction right! from the bottom of my heart i hope u got the second part right too.
Anyway thanks for sharing the info which i think is very kind of u.Mattoru is also a nice guy in my opinion hope both of u can communicate amicably.
I hope beside of learning to trade like u i can also put to practice into my daily life 'it's nice to be important but it's more important to be nice'
Hub: Thanks for the kind words. I hope ALXA plays out well for us as well. I don't really consider that I have gotten anything correct here until that happens. My shares are barely in the money as of today. I do think we will make a good return here as we move closer to the PDUFA. There just is not a nearby catalyst to push ALXA downward in my opinion except for the general market. The general market is sluggish and may hold ALXA back for a couple weeks. Finally I believe it will move up to the level I have listed.
People worry about the manuf. facility inspection. I agree with a poster that said this info likely will not come out until the FDA communication related to the decision on the drug. Those waiting to buy shares when they see this info may be too late. I don't see this as a problem prior to the PDUFA. This is just my opinion and I can always be wrong.
I do believe we should treat people with kindness. It just makes the world a better place. As for Matt and I our opinion of one another is really baseless in a discussion on ALXA. I don't personally know him, so I cannot and would not know of his character. Anything I have said was not against him personally but only against what he posted.
Good luck all!! I hope ALXA will make us some money. If it does not all I have written was just a bunch of noise. Happy investing!!