Replies to post #12403 on Intellipharmaceutics International Inc. (IPCI)

[hogfan2]

Agreed doog...I don't see a phase111....and the way IPCI came back on the latest FDA decision was quite impressive....the data used to thwart FDA's previous decision to ask for more data must have been kick ass....IPCI has been connecting the dots quite nicely...haven't seen any missteps... Damn Drug mafia aka FDA needs to get busy like they were a private company not the govt bureaucracy that it is...hog

[no2koolaid]

As I said, all just my opinion. But no business operates without consideration of the external context and, to that end, the socio-political issues cut both ways. How so? Given past accusations of unfair or unequal treatment by the FDA of some pharma firms, the FDA wants to ensure they are creating a level playing field. Ergo, how does one company's BE success for" similar" drugs allow them to bypass an efficacy trial (even granted a 505b2 approach) and another not? In the past, it would. But the FDA has allegedly taken a new approach (supposedly less influenced by certain factions) and it is seeking to be "more fair" not merely expeditious. Again, that is simply my reading. In the near term we will know. But, I think IPCI needs to prepare for that scenario, even if it does not materialize. To not is folly.