Hi All
First of all, I have to a admit to being angry at PXS over the last couple of weeks. Like most on here my investment is worth about a third of what it was a month ago. I have held for 7 years.
Most of that anger was at Dr Robertson selling his shares before the negative trend vote rather than the drug Bronchitol or the efforts of PXS in getting it approved.
In the last few days my thoughts have moved on to why the EMEA would not approve Bronchiltol and what can I do to change that. After all their job is to approve drugs that have a positive benefit/risk profile.
No quality issues or safety issues have been raised so the no trend vote is based up the perceived benefit or not of Bronchitol.
I have spoken to Alan Robertson this week and in summary he expects the June vote to be a no as previously stated. The EMEA will then have to outline their rejection reason which he expects will be on clinical meaningfulness.
That is to say they do not think that the response on Bronchitol justify's approval. PXS will then appeal this.
In the mind of PXS the overall 8% improvement in FEV1 is significant. I tend to agree on the basis of a patient losing 2% a year lung function and living to only 30 years of age. We also have to remember that Bronchitol held that 8% improvement for the full 12 months.
In light of all this I am on a mission now to see what patients who have used this drug actually think. After all we can argue about it all day on HC but they are the ones who the EMEA should be listening to.
In part 2 I will post some of the comments from users that I find.
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- part 1 -some patients who have used bronchitol
part 1 -some patients who have used bronchitol
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