Isotechnika Pharma Inc IPHAF

Another Interpretation

[ChiChi3]

After reading all the interpretations on the NR, I think there may be one more (forgive me if it has already been suggested).

From the NR: "This meeting has been cancelled to allow time for the resolution of several outstanding issues."

I think this is a huge stretch, but could this be interpreted to mean that if these "several outstanding issues" are addressed, there would have been no need for a meeting?  In other words, the NDA is such a slam-dunk that an Advisory Committee meeting was not needed and solving the "several outstanding issues" just repaces the need for the meeting.  If this is plausible, then this would be hugely positive for the stock.

Any thoughts?

Chi.

[WASKERWISK]

“I think this is a huge stretch, but could this be interpreted to mean that if these "several outstanding issues" are addressed, there would have been no need for a meeting? “That would be great, but Lux doesn’t know what those issues are and isn’t expecting to know what those issues are before the action letter issues. It doesn’t seem very likely therefore that those issued can be

[blog]

So the hope now is a CRL that is class 1?

[macbethorfaust]

Here is the FDA review process for those who wish to review it. https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm The FDA, if it does not approve, issues a complete response letter.  As indicated in the excerpt I will post after this, the issues raised in a CRL can be minor (just need more information or something clarified) or it can be major (more studies required)

[macbethorfaust]

Here is the excerpt I said I would post from the FDA website:“Bumps in the RoadIf the FDA decides that the benefits of a drug outweigh the risks, the drug will receive approval and can be marketed in the United States. But if there are problems with an NDA or if more information is necessary to make that determination, the FDA may issue a complete response letter. Common problems include