Bioelectronics Corp (BIEL)

[GetSeriousOK]

A couple of months ago, someone asked what Kelly was doing to prepare for the NOPAIN Act. I suggested that she wasn't doing anything other than sitting on her hands waiting for Ilfeld to publish his Opioid Pilot Study.

For which I was, of course, mocked and ridiculed, as I am mocked and ridiculed every time I try to offer an idea or analysis.

Yesterday, Kelly proved me right. A FB poster asked "Kelly thanks for responding I understand your point, can you at least tell us if BIEL is taking any steps in favor of NOPAIN Act that's coming in few months?"

Here's Kelly's reply:

we do not yet have access to the data from Dr. Ilfeld's study as it was investigator sponsored and paid. We assume that the results are positive, and expect to be able to use that data to substantiate our position that RecoveryRx should be covered under the NOPAIN Act.

That's it. That's all she's doing. I don't know what else she spends "a minimum of 12-14 hours every day" doing, but it's not preparing for the NOPAIN Act.

And I think Kelly is in for an unpleasant surprise, because Ilfeld said in the "Study Outcomes" section of his Opioid Pilot Study:

Study outcomes: This is an exploratory pilot study to assist in planning subsequent definitive trials and we therefore have no data analysis plan. 

Ilfeld is taking a different approach in his SofPulse opioid study -- he is going to analyze the data for pain, although he isn't going to analyze data for opioid use in THAT trial either (bolding emphasis mine):

Continuous, normally-distributed data will be reported as mean ± standard deviation. Nonparametric continuous or categorical data will be reported as median [10th-90th percentiles] or precents, as appropriate. Comparisons of independent samples will be performed using Student's t-test for parametric continuous variables or Mann-Whitney U test for nonparametric or categorical variables. The Chi Square test and Fisher's Exact test will be used for differences in proportions, as appropriate. P<0.05 will be considered statistically significant for the primary outcome. Results of comparisons in secondary outcomes will be interpreted as suggestive, requiring confirmation in a future trial before considering them as definitive.

It's conjecture to predict how the CMS will interpret Ilfeld's results. It's a pity that BIEL doesn't have any other clinical proof of opioid reduction and hasn't spent any time or resources on trying to GET clinical proof. I know they don't have money for clinical trials but if the NOPAIN Act is the only real hope for the future here, as it seems to be in the eyes of some of the company's loudest cheerleaders, maybe they need to find some money and stop sitting on their hands.