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MackG

09/14/18 4:26 PM

#241084 RE: seek the light #241074

seek the light,your rational based on simple logic entirely supports your conclusion. Of course management monitored patient outcomes the the trial progressed, and by the end of the trial, they had a VERY good idea of the effectiveness of the drug, or the lack thereof. As you said, the company's actions fully support that we have a blockbuster in the works, and in time, a deal that will boggle the minds of lots of folks here.
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Amatuer17

09/14/18 6:53 PM

#241096 RE: seek the light #241074

“Given the design of the trial and contact with the CROs and clinical site visits, it was possible to have a very good feel of the results of the trial even though it was blinded. It is a simple exercise in math to do so. “

Assuming this is true - they would have noticed the results of improvements. If the results were great will Leo stop payment to CRO? He would have jumped the guns and got the results.

The fact that he delayed it by 9 months tells us that he guessed the results are bad and so he did not pay CRO.
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MinnieM

09/14/18 8:49 PM

#241115 RE: seek the light #241074

I disagree with your thinking on this. Let's just suppose there were a lot of good results. The problem I see is the company not knowing what percentage of those are on placebo. This may be less of an issue at the higher doses, but, it's an issue in psoriasis trials.

Let's hope you are right and I'm wrong. ;)

They need that signed term sheet to become a signed agreement. That would change everything.

We also may have the answer to why Leo contracted with drug manufacturers so early being cash poor. Not only might they need it for the FDA meeting, they may have been required to prove to the interested party that the drug could be manufactured in large doses. It's worthless if it can't be.

If this is the case, it appears to be a matter of robbing Peter (CRO) to pay Paul (drug manufacturer for deal). I'd agree with that decision any day.

Of course, this is all speculation in my attempt to wrap my head around the current situation. The deal being worked on may have simply required a number of expenses to move the deal forward that simply had to be taken from funds allotted to CRO. If a deal ensues, the CRO will end up being paid.

We may yet get a deal closed. Another issue is timing. And, there are no guarantees of anything going right moving forward.

Good luck all.









In Reply to 'seek the light'
frrol......Wrong it is not confirmation bias at all. It is the product of logical reasoning and math applied to the unique design of the Phase 2B trial. And my response was too daubersUP post that contained the following Statement from the company 10K:
"We monitor patient enrollment, the progress of clinical studies and
related activities to the extent possible through internal reviews of
data reported to us by the CROs, correspondence with the CROs and
clinical site visits."
This statement confirmed what i had thought the company was doing in regards to keeping current with what was being SEEN by those running the trial. Given the design of the trial and contact with the CROs and clinical site visits, it was possible to have a very good feel of the results of the trial even though it was blinded. It is a simple exercise in math to do so.

So i am awaiting word that you have used your very good intellect to understand what i have deduced months ago. And BTW i think it was a stroke of genius on the part of management to configure the design of the arms of the trial in this way. It is such pure genius that it had to be done on purpose.