Isotechnika Pharma Inc IPHAF

from Bio Runup

[gmcsle]

I 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!

[NorthStarr]

How about sharing your correspondence  from Launa instead of giving us your twist on what she said??? Seems odd to me the COO of the company took the time to respond to you during this time.Cheers

[macbethorfaust]

Northstar gmclse was only pasting in a comment on biorunup’s site.Biorunup’s perspective is a valid one but remember he is in these plays only for the run up i.e. in situations where the run up is pretty much a given (a pretty good play actually when you think about it)).  When things get uncertain he bails.   And the fact that he didn’t know what was meant by an “action letter

[WASKERWISK]

Well here’s the thing though about the market.  Is 27 cents the price for a delayed PDUFA i.e. is the perceived delay already priced in?  I mean I for one am already assuming that there will be a delay.  Or will the drop be significant if it is delayed?   Curious to see. Obviously if we are back on things will bounce back rather tremendously and probably well above where

[NorthStarr]

First of all my apologies to GMCLSEMacbethorfaust, thank you very much for the clarification. I do agree the perspective is a valid one. What got me was they were claiming to have had correspondence from the COO. Thanks for your post, very well said and I couldn't agree more with your take on things.Here is to hopefully good things to come.Cheers