Therma Bright Inc V.THRM

Reason(s) For Clinical Trials

[Smokey1958]

Throughout the pandemic companies that have produced a rapid antigen test and applied for an EUA had at least 2 FDA hurdles. The first was to supply test data to demonstrate the device worked (which included no cross reactivity issues) and could be used in a clinical setting and/or by health care professionals in a public setting. That would represent their first submission for approval. Months later (over the last year anyway) was a second submission for application for at home use.

While purely speculation on my part it appears THRM either through its summary of invitro tests and/or its trials in Brazil  paased the first test ...with the exception of the cross reactivity tests which would have been carried out sometime after Rob's second last interview. This is when he mentioned this. It also seems that because of timing, the FDA "packaged" the application process into one ...to include the at home clinical trials as part of one whole submission. This is the critical piece for me in believing that unless something went horribly wrong with individuals being able to take their own saliva samples that an FDA EUA has never been a matter of if but instead of when it would be provided.

It makes no sense to have otherwise carried this on for months!!!

[mooseslayer]

I agree...I think that the FDA Ask for these latest trials was to allow for Home tests. That is why they also asked for proof manufacturing was in place for a minimum 500K test per week. If they had found something wrong with the device or the data they would have already been dismissed.

[nrv090909]

I agree. FDA would never ask for minimum 500K proof of scaling if they thought Acuvid was garbadge. It will get approved, that is why they asked for minimums. I think once they submit data it is approval. Great time to buy cheapies right now in the 30's. IMO. Good luck to all longs, shorts and shorters and day traders. 

[Commoncents]

It's going to get approval soon imo. Too many things adding up. I added in the 30's today: it was too tempting not to add with FDA coming imo. 

[Trueblood]

It's a production pre requirement for all submissions has nothing to do with Acuvid.