Remember Isotechnika? ISA.TO (or IPHAF) is the company whose FDA Advisory Panel was cancelled with only a few days notice. The explanation the company gave was vauge at best. However, the company claims the Priority Review PDUFA date of 8/3/10 for Voclosporin is still valid, and they expect to hear from the FDA by that time. That date is less than 1 week away, and although it is a VERY risky play, some may chose to jump in last minute for a possible run-up or even an unexpected approval.
Take a look at the chart for ISA.TO over the past few months:
Isotechnika is currently trading at about half of its run-up peak. So why did the FDA Panel get canceled? This is from their official press release:
This meeting has been cancelled to allow time for the resolution of several outstanding issues. The agency intends to continue evaluating NDA 22340 and, as needed, may schedule an advisory committee meeting in the future.
What? What about the PDUFA date of 8/3/10? The PR continues:
At this time, the FDA has not communicated all the outstanding issues to Lux for the uveitis application,” stated Dr. Robert Foster, President and CEO of Isotechnika Pharma. “They await the action letter from the FDA which is expected on or near the PDUFA date of August 3, 2010 for further clarification.
Clear as mud. However there is still the possibility for a run-up to the 8/3/10 date. Will I buy shares? Probably not, and as of right now I have no position.
To read previous write-ups on Isotechnika, click on the links below:
Run-Up Play ISA.TO (IPHAF) +30% with One Week Until FDA Panel
ISA.TO (IPHAF) June FDA Panel and Priority Review – $0.27
To discuss ISA.TO, visit the BioRunUp Forums
Disclosure:
No Position
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thought about it but the “several outstanding issues” part doesn’t sound promising at all.
It is not clear as mud. It is crystal clear. By August 3 they expect an FDA action letter in which all the outstanding issues will be communicated and detailed. There is no chance of approval on August 3.
man, hard to gamble on this one, volume extremely low!!
It makes it even riskier!
I am staying away from this, but I figured I would pass the opportunity on, as it does have a PDUFA date in a week…
I agree with John, that volume is extremely low. getting your hands on some seems like a challenge in itself
Im Holding 3000 shares and will sell this on thursday regardless of the price. I averaged in @ .30