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News Focus
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smm886

09/11/20 1:59 PM

#20071 RE: TraderInvictus #20069

Why announce results while there's distribution questions up in the air? You have to remember that as an investor, your bias leads you to believe that the best course of action is what will affect the stock price in the short term. As business people, NeuroRX / Relief / Glaxo are all looking at this in much longer horizons (1 year, 3 year, 10 year) and all the uses for it. The long game is that you answer any and all outstanding questions (distribution capabilities, outstanding shares, financing structure, marketing announcements) before you drop trial data. The best path to success is one not filled with ammunition for naysayers

STAY RESILIENT
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nelskof

09/11/20 1:59 PM

#20072 RE: TraderInvictus #20069

No, not at all. 102 patients is very small. Even 144 is small. Most therapeutics are running in the hundreds. Where vaccines are in the thousands.

I wouldn't be surprised in the least bit if the DMC and FDA said finish the trial, get more data and then we'll talk.

Javitt alluded in the video the FDA was bending any rules "at least not with us".

I need to go back and listen again later about the pharmacy being re-purposed to create the IV version. I guess they'll continue to do that? The inhaler is the partnership.
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Whalatane

09/11/20 3:00 PM

#20091 RE: TraderInvictus #20069

Insight ..The IV trial was powered for 144 patients . This means in my layman understanding of bio stats ....that based on the risk profile of those enrolled ...they need 144 patients in long enough to hopefully get a statistically significant result ...less than a P value of .05 ...and preferably a P value of .01 .....So they could say to the FDA that they have data they believed to be 99% true ...P value of .01 .

They have to rule out / reduce , the role of chance.

So far we have data on 21 ? in an open label trial that's very encouraging BUT its not enough to say with 99% certainty ( P value .01 ) that we would see the same results with the next 21 patients.

They also need data on who RLF-100 works best on and best time to prescribe ( my guess is soon as a hospitalized patient needs O2 support....ie BEFORE going on a Vent )

If RLF-100 is a good as we hope it is then the FDA will want this in as many hospitals asap ....as long as they are confident in the trial data .

What I would like to see is a notice that the trial is fully enrolled ...then we can count down to read out.

By the way there are trials that could have been stopped at an Interim analysis ...but the DMC and Co decided to run to full completion to get the most detailed results ( and best stat sig reading ) possible ...Amarins Reduce It trial being the one I'm most familiar with

Kiwi
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trademax42

09/11/20 3:20 PM

#20098 RE: TraderInvictus #20069

I believe they needed certain sample size in both groups to run statistical analysis. imo

$RLFTF

Was the DMC results not compelling enough for an early halt and a request for an EUA?