GREY:IPHAF - Post by User
Post by
gmcsleon Jun 24, 2010 9:45pm
623 Views
Post# 17220445
from Bio Runup
from Bio RunupI have received email correspondence from the Chief Operating Officer of Isotechnika, Launa Aspeslet. In summary Dr. Aspelet stated that the August 3rd, 2010 FDA PDUFA date is still valid. The “action letter” that was mentioned in yesterday’s press release was referring to the standard FDA decision process of issuing ”Approval” or a CRL. It was not referring to any specific requests from the FDA. Isotechnika states that they have not been provided with any additional details regarding the “outstanding issues” mentioned by the FDA in the meeting cancellation PR.
My opinion: The cancellation of the FDA Panel was an event that I can not remembering happening in the past. The FDA usually requests an additional 90 days to review anything, take for example QCOR‘s NDA. Because of this I will not be taking another position in ISA.TO (IPHAF). I feel that the official CRL (Complete Response Letter, or FDA rejection) may come at any time, which may send Isotechnika down to pre-FDA Review prices in the $.10 – $.19 range. As always, this is just my opinion and you need to decide for yourself how to invest. If no early CRL is issued, ISA.TO may climb back to $.40. At this point, it is too risky for me.
Me Too!