Well, we have MANY things to consider after the release of the data:
It is VERY difficult to demonstrate statistical significance. This is why many companies don't make it to market.
It is even more difficult to demonstrate statistical significance ON TOP of all other drugs being used with all the patients. Think about it, we need to show that are much-much better when everybody is given the SOC, that is, the BEST drugs in existence, the standard of care.
Yet we did show improvement. Vyrologix (VX) works, imo there has been lots of de-risking for the company with the results obtained.
Management, to a great extent, is NOT responsible for the results of the trial. They take the drug to test through the proper regulatory structure and then the drug performs (or not).
We had a bit of a bad luck with the splits in patient's age. But this is the way it is.
We need to understand the differences between Severe and Critical form the scientific perspective. A drug sometimes finds it easy to help people less sick that more sick. We have found out that ours works better with the very sick. This is golden. However, there must be a "transition", that is, WE SHOULD HAVE BENEFIT IN SEVERE AS WELL there is not a switch from work to not-work. We better understand what happens in this stage.
There is a big difference between outright approval (were statistical significance is the norm) and EUA (were demonstrable benefit in absence of alternatives is the norm). We showed benefit, we are safe, we are backed up for the science in many scientific papers AND the numbers in our CD-12.
It would be criminal not to issue a EUA and keep on gathering data afterwards with the use of the drug. Just criminal.
But I don't want to repeat myself on my opinion of FDA. Hopefully other countries will show more "mental sanity" and care for their own citizens
In regards to next trial we cannot miss the end-point if this is hospital stay. We are completely de-risked in this one.
I am looking forward to hear about Oncology, and NASH (do we really have 40 patients enrolled already ??), plans for LH trial and BLA submission.
We are good ... in spite of FDA.
It is VERY difficult to demonstrate statistical significance. This is why many companies don't make it to market.
It is even more difficult to demonstrate statistical significance ON TOP of all other drugs being used with all the patients. Think about it, we need to show that are much-much better when everybody is given the SOC, that is, the BEST drugs in existence, the standard of care.
Yet we did show improvement. Vyrologix (VX) works, imo there has been lots of de-risking for the company with the results obtained.
Management, to a great extent, is NOT responsible for the results of the trial. They take the drug to test through the proper regulatory structure and then the drug performs (or not).
We had a bit of a bad luck with the splits in patient's age. But this is the way it is.
We need to understand the differences between Severe and Critical form the scientific perspective. A drug sometimes finds it easy to help people less sick that more sick. We have found out that ours works better with the very sick. This is golden. However, there must be a "transition", that is, WE SHOULD HAVE BENEFIT IN SEVERE AS WELL there is not a switch from work to not-work. We better understand what happens in this stage.
There is a big difference between outright approval (were statistical significance is the norm) and EUA (were demonstrable benefit in absence of alternatives is the norm). We showed benefit, we are safe, we are backed up for the science in many scientific papers AND the numbers in our CD-12.
It would be criminal not to issue a EUA and keep on gathering data afterwards with the use of the drug. Just criminal.
But I don't want to repeat myself on my opinion of FDA. Hopefully other countries will show more "mental sanity" and care for their own citizens
In regards to next trial we cannot miss the end-point if this is hospital stay. We are completely de-risked in this one.
I am looking forward to hear about Oncology, and NASH (do we really have 40 patients enrolled already ??), plans for LH trial and BLA submission.
We are good ... in spite of FDA.
14
1
