Data analysis should be complete any day now (if it's not already) and perhaps the news will be delivered to us (hopefully good!). I wouldn't hold these deadlines from March's PR to the heart, since it takes time to evaluate everything. Better for them to take their time instead of missing critical analysis.
APPY stated it should release the info and file with the FDA by end of Q2. Those of you inpatient souls yelling no news etc, well go away from your computers. We might still have a while to wait but hopefully it's for the best.
Therefore, anything can happen from now on. Any day, any time...Don't be caught with your pants down or on the sidelines. Just sayin'
here's the bottom line.... if you're long, you have made an investment (admittedly, a wager) that this is a viable, worthwhile, demonstrable, necessary test that will ultimately be approved, marketed, and used throughout the world. It does not matter if if takes them 4 or 6 or 8 or 12 weeks to finalize the data presentation. If you are wrong, you lose. If you are right you win (big). But you can't change your wager based on last minute fear, rumor, or a couple more weeks time to prepare the presentation.
Well said; it's all or nothing with bio stocks pre-FDA approval. A few extra weeks (or even months) mean nothing compared to final test results. APPY's chances this time are as good as they will ever get. If they corrected the things they know they could after the 600 person trial, they should get over the hump this time.
As you all know, Japan's 2nd largest pharma just bought out US pharma OSI that had $428 mil in annual sales for close to $57.50 a share. That's sales, not profits. Yes it's insane but if APPY gets FDA approval, it's hard to tell how high this stock will go based on US sales, let alone world sales.
kiksbutt, one encouraging info you got from Mr. Pusey that he added into the responce "they anticipate to file the 510 in late Q2". Why put that in there if you don't have too and especially if he knows the results are bad. Maybe reading too much into it but.....
Thanks for posting your attempt to contact the company this weekend.
However, you state they should take their time and not make any mistakes, that is not quite how it works. The data colleciton is being done by an IDMC who do not make mistakes. These independent data collection sources are basically failsafe in their analysis of what they get. However they have no say in trial design and similiar to an unaudited financial statement, they only provide stats on the information they get. However in this case it is like an audited financial statement as they have been tasked with the job of auditing the numbers they receive. Your new CEO and CSO are very competent and there will be no mistakes this time.
In BIO land the term "unambigious" comes to mind. However that does not mean the numbers will be favorable, just accurate. If the test works, and I am in your camp that the test is a good one, then the numbers they report to APPY will favor approval and off we go. Lets keep our fingers crossed but trust this, there will be no mistakes this time. gl