Isotechnika Pharma Inc IPHAF

Not so serious

[biodelatech]

The Fda says:
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.
https://www.federalregister.gov/OFRUpload/OFRData/2010-15352_PI.pdf
What does it mean?
If they the issues another meeting will be scheduled.
There's nothing sinister about that.
Maybe fast-track has been too fast for Lux to get everything right.
If there were major flaws the FDA could have simply rejected the NDA .
But the FDA simply grants more time for the resolution of issues.
That has happened many times before.

[biodelatech]

The Fda says: 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. https://www.federalregister.gov/OFRUpload/OFRData/2010-15352_PI.pdf What does it mean? If Lux resolves the issues another meeting will be scheduled. There

[labumba]

I agree that the issues are not seriuos type and can be resolved timely....thats why ISA didn't know all the way and Lux was not aware of ( ? )....now Lux wants an action letter to confrim the issues with FDA..if it is a drug safety issue, the NDA could have been rejected.....all the trials indicated the drug is good

[macbethorfaust]

we have no idea frankly if the issues are serious or not or, more to the point, how long it will take to resolve them - what if another study is required?  then we are toastthat said, I am rather relucantly back in - same number of shares as before but pulled out some cash so maybe will be a slight postive in the end - and the market doesn't seem to think that it was as bad as I did so