I've had a little time to examine this update and I would like to share a few observations.
1. In the next week we plan to ask the FDA through counsel, as other companies have, for a conditional but immediate EUA approval subject only to completion of testing. This conditional approval will replace the Pre-EUA designation and allow the company to begin large scale preparation of kits.
Here, here. IF this kit will do what DECN says it will do, then some very preliminary test results should be able to let DECN proceed. If other companies can get approval for their shaky processes then DECN should, too, especially with help from the Congressmen.
2. we have had two long conversations with FDA staff and management,
These conversations are important to educate the FDA (again, seems like DECN's cross to bear) and help them understand that this is a different solution. Good!
3. We believe we have completed discussions and have come to an understanding with the FDA on all of the testing required to receive the EUA. We plan to engage a specialty reference laboratory to complete this testing in the next 10 days. Testing should take about a week.
So maybe a couple of weeks-ish to get this completed. Think how many companies would LOVE to be in this position with the FDA. Well-defined path forward. Good.
4. On April 13, 2020 the company engaged a publicist and a lobbyist. ...In addition, the company's lobbyist has engaged several influential members of Congress...The Congressmen have agreed to carry the ball on behalf of the company, beginning with direct communication with the Pence Covid-19 Task Force. This process began on April 20. The company's goal for GenViro! is not just to receive EUA approval from the FDA, but when this approval is received, to become the go-to testing solution, in demand by Professional organizations as well as Fortune 500 companies, even sports teams.
Are you kidding? How great is all this? How many companies would like to have this kind of access? IMO, this is how stuff gets done in D.C. Does any other company have ANY hope of becoming the go-to test? Not that I have heard of.
5. seeking to reopen for business in the next month or two. This is perfect timing for the availability of kits. Some of these businesses have already contacted the company and even tried to place large purchase orders for GenViro! Swift kits, using the first in line principal, so that they may test and retest returning employees. No other test kit can accomplish this. The company has also accepted inquiries from restaurant chains and drinking establishments -- places where people congregate. We believe an outgrowth of this new market will be that off-duty nurses, medical technologists licensed to draw blood, and off duty pharmacists will be in large demand. The company has even been contacted by a sports franchise/league for the testing of players and ticket holders.
Wow. As has been observed before, we won't have to wait until August/September for the first volume production. Is there any way that the Defense Production Act could aid the manufacturing (like getting priority for raw materials, etc.)? I don't have any illusions that the FDA loves small companies but the ability to solve the problem might speak volumes and get the necessary support. Also, I've got nurses, respiratory therapists, etc. in my immediate family that might participate in the testing for companies...think I'll talk to them about this opportunity... Good.
6. DECN views this as an opportunity to become the first company to provide an all-in-one, immediate result, individual at-home Covid-19 test kits with its GenViro! Swift kit for at-home use.
I agree, this is unique. The big question in my mind at this point is how does the individual at-home test person communicate the results to "the authorities?" If you test negative, how do you prove it to your boss? If you test positive, what is to stop you from lying about the result and just going to work anyway? To assume everyone is honest in the face of needing to provide for your family and being afraid of retaliation seems unrealistic. How, exactly, do the results get cast in stone?
7. We intend to file our stand-alone EUA application for the individual use GenViro! Swift kit by May 1. We anticipate the application to include data gleaned from our GenViro Professional kit application. We also anticipate a request to direct us to conduct a donor study of a modest group of donors. We have already identified a group in Pennsylvania to make use of the Genviro! Swift Home kit. Additional testing required for this kit is anticipated to take less than a week.
Sounds like mid-May to me. That is still pretty fast.
8. PharmaTech Solutions GenViro! "Swift Kit" testing kit will provide the quick answers individuals and employers need. It provides results on the spot with no delay. While the FDA assesses how to move forward with this technology, the company is moving to work with a large health care products distributor who has already received requests for the GenViro! Swift kits. Outlets ranging from Fortune 50 corporations to professional sports leagues have shown strong interest. The company estimates it will be asked to produce 1 million "Swift Kits" per month through the end of the year just for the "back to work" markets, based on the rapidly building demand.
A million a month seems light to me but what do I know. Once one company is able to open then HOW they did it seems like it would spread like wildfire. When your competitors start opening up and taking your customers you might be very motivated to find out what they did and do the same thing.
All-in-all there is a lot to digest in this news release. Thank you , KB, for the update. I don't see anything negative, per se, just a question about how a home tester proves/communicates their result. The corporate/ professional will be given the benefit of the doubt or will have an established process to record the results "for the record." Could there be a central database where all results are recorded? Seems a little Big-Brother-Creepy but I'm sure there are better answers.
Take care of yourself, Keith. I can't wait to see what you come up with next. Go DECN!
1. In the next week we plan to ask the FDA through counsel, as other companies have, for a conditional but immediate EUA approval subject only to completion of testing. This conditional approval will replace the Pre-EUA designation and allow the company to begin large scale preparation of kits.
Here, here. IF this kit will do what DECN says it will do, then some very preliminary test results should be able to let DECN proceed. If other companies can get approval for their shaky processes then DECN should, too, especially with help from the Congressmen.
2. we have had two long conversations with FDA staff and management,
These conversations are important to educate the FDA (again, seems like DECN's cross to bear) and help them understand that this is a different solution. Good!
3. We believe we have completed discussions and have come to an understanding with the FDA on all of the testing required to receive the EUA. We plan to engage a specialty reference laboratory to complete this testing in the next 10 days. Testing should take about a week.
So maybe a couple of weeks-ish to get this completed. Think how many companies would LOVE to be in this position with the FDA. Well-defined path forward. Good.
4. On April 13, 2020 the company engaged a publicist and a lobbyist. ...In addition, the company's lobbyist has engaged several influential members of Congress...The Congressmen have agreed to carry the ball on behalf of the company, beginning with direct communication with the Pence Covid-19 Task Force. This process began on April 20. The company's goal for GenViro! is not just to receive EUA approval from the FDA, but when this approval is received, to become the go-to testing solution, in demand by Professional organizations as well as Fortune 500 companies, even sports teams.
Are you kidding? How great is all this? How many companies would like to have this kind of access? IMO, this is how stuff gets done in D.C. Does any other company have ANY hope of becoming the go-to test? Not that I have heard of.
5. seeking to reopen for business in the next month or two. This is perfect timing for the availability of kits. Some of these businesses have already contacted the company and even tried to place large purchase orders for GenViro! Swift kits, using the first in line principal, so that they may test and retest returning employees. No other test kit can accomplish this. The company has also accepted inquiries from restaurant chains and drinking establishments -- places where people congregate. We believe an outgrowth of this new market will be that off-duty nurses, medical technologists licensed to draw blood, and off duty pharmacists will be in large demand. The company has even been contacted by a sports franchise/league for the testing of players and ticket holders.
Wow. As has been observed before, we won't have to wait until August/September for the first volume production. Is there any way that the Defense Production Act could aid the manufacturing (like getting priority for raw materials, etc.)? I don't have any illusions that the FDA loves small companies but the ability to solve the problem might speak volumes and get the necessary support. Also, I've got nurses, respiratory therapists, etc. in my immediate family that might participate in the testing for companies...think I'll talk to them about this opportunity... Good.
6. DECN views this as an opportunity to become the first company to provide an all-in-one, immediate result, individual at-home Covid-19 test kits with its GenViro! Swift kit for at-home use.
I agree, this is unique. The big question in my mind at this point is how does the individual at-home test person communicate the results to "the authorities?" If you test negative, how do you prove it to your boss? If you test positive, what is to stop you from lying about the result and just going to work anyway? To assume everyone is honest in the face of needing to provide for your family and being afraid of retaliation seems unrealistic. How, exactly, do the results get cast in stone?
7. We intend to file our stand-alone EUA application for the individual use GenViro! Swift kit by May 1. We anticipate the application to include data gleaned from our GenViro Professional kit application. We also anticipate a request to direct us to conduct a donor study of a modest group of donors. We have already identified a group in Pennsylvania to make use of the Genviro! Swift Home kit. Additional testing required for this kit is anticipated to take less than a week.
Sounds like mid-May to me. That is still pretty fast.
8. PharmaTech Solutions GenViro! "Swift Kit" testing kit will provide the quick answers individuals and employers need. It provides results on the spot with no delay. While the FDA assesses how to move forward with this technology, the company is moving to work with a large health care products distributor who has already received requests for the GenViro! Swift kits. Outlets ranging from Fortune 50 corporations to professional sports leagues have shown strong interest. The company estimates it will be asked to produce 1 million "Swift Kits" per month through the end of the year just for the "back to work" markets, based on the rapidly building demand.
A million a month seems light to me but what do I know. Once one company is able to open then HOW they did it seems like it would spread like wildfire. When your competitors start opening up and taking your customers you might be very motivated to find out what they did and do the same thing.
All-in-all there is a lot to digest in this news release. Thank you , KB, for the update. I don't see anything negative, per se, just a question about how a home tester proves/communicates their result. The corporate/ professional will be given the benefit of the doubt or will have an established process to record the results "for the record." Could there be a central database where all results are recorded? Seems a little Big-Brother-Creepy but I'm sure there are better answers.
Take care of yourself, Keith. I can't wait to see what you come up with next. Go DECN!
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