IMV Inc IMVIF

RE:Need for Explanation

[qwerty22]

It's very hard to understand because even though we don't have most of the details we do have some of the big things and we do have an insight into the international regulators expectations to start a Ph1 and both those suggest no delays.

For example

They were talking about completeing GMP manufacturing fairly early on and they've manufactured for a number of trials before, they should have that box ticking exercise under control.

Pre-clinical data, they talked about the level of evidence needed to publish being high, I took that to mean they needed to do more expts to collect more data for the publication. Could that have bled into the regulatory process as well? They have stated they have neutralizing data which is a big part of efficacy at this stage. But the science is constantly moving on it could be the regulators are adding to the list of evidence of efficacy/safety as new things are learnt about the disease.

They could have eff'd up as well, like you say.

Its hard to fit Medicago's route to Ph1 approval with what is happening with IMV given they put the application in late July/early Aug.

Hideaway wrote:

Management doesn't seem to understand the frustration caused by their failure to communicate the reason for the HC delay in granting approval to commence the ph.1.
This is more than just the slowness of the bureaucracy. A more likely reason is that there was insufficient documentation filed with the submission and subsequent follow up queries from HC which the Company are having difficulty answering to HC's satisfaction.Hard to comprehend what the issues are but don't expect management to give us any details if all or part of the delay is of their own making.
There is also the question as to why the delay in publishing the preclinical results in a reputable journal?

Some of the more knowledgeable board members may have better explanations.Sure would appreciate any imput that could offer more clarity.