Dance floor is cleared
Not totally. Trump's FDA made it easier for companies to get their feet in the door, but there are still some business obstacles.
The original FDA EUA guidance for coronavirus, issued on February 27, 2020 promised to grant EUA to companies who developed a kit and then administered it themselves. This allowed commercial laboratories to be granted EUA, and administer the kit testing in their drawing stations. There are 28,000 drawing stations/centers in the US.
Closed door and compounding pharmacies, pharmacies that service nursing homes could cobble together kits, but pharmacies could not offer someone elses kits, which were unapproved to walk in clientel who just walked in several months prior to get a flu shot. Still, this EUA procedure allowed for many exemptions but did not open the door for DECN, even though they made initial application with the FDA. This is a major reason why the availabilily of kits is still today limited. DECN probably figured they had nothing to lose.
On March 16, the FDA revised its guidance, that opened the door wider and included companies like DECN. A pre-EUA step was added to the guidance which also allowed for kits to be sold (government calls it distributed) to entities that offer professional services by professional or semi-professional people under the management of professionals. Pharmacy assistants could administer a kit to walk-in or to parking lot clientel. The med tech who draws blood in a laboratory drawing station are now qualified -- at least the drawing station is. And, home health professionals (visiting angels etc) could administer kits. DECN's kit forecast is based on this change in guidance.
There are more than several coronavirus test kit contenders who saw their stocks run up and up, and raised tens of millions in equity capital who in another era would be called frauds.
But, the new EUA does not allow for direct sale (distribution) of kits to individuals through mail order, retail sale or places like Amazon. That comes later.
No matter what the people who know it all or the naysayers, or the BDS people tell you, DECN is in a great space. Mr. Berman is in the kit manufacturing and distribution business. Several here and many on the iHub board want him to be in the stock price engineering business and want him to go balls to the wall for an FDA pre-EUA, and do anything or say anything to achieve this. Mr. Berman, however, is in this for the long haul -- he has a technology business to run.
He is more interested, in fact laser focused, on the market and for doing good for humanity, and he believes the stock price will follow. Others don't care. Nonetheless, Mr. Berman is CEO and has the authority to make these calls. Naysayers, know-it-alls, and people with BDS do not have this right, unless they step up and take over the company.
By the way, Trump may not have had a hand in all of the national engineering details of this epic battle against the invisible enemy, but he will be rewarded with both a second term and a great place in history for marshaling the resources in the US. What Mr. Berman is enduring is a microcosm of what Trump has to endure. Both will be big winners.
Not totally. Trump's FDA made it easier for companies to get their feet in the door, but there are still some business obstacles.
The original FDA EUA guidance for coronavirus, issued on February 27, 2020 promised to grant EUA to companies who developed a kit and then administered it themselves. This allowed commercial laboratories to be granted EUA, and administer the kit testing in their drawing stations. There are 28,000 drawing stations/centers in the US.
Closed door and compounding pharmacies, pharmacies that service nursing homes could cobble together kits, but pharmacies could not offer someone elses kits, which were unapproved to walk in clientel who just walked in several months prior to get a flu shot. Still, this EUA procedure allowed for many exemptions but did not open the door for DECN, even though they made initial application with the FDA. This is a major reason why the availabilily of kits is still today limited. DECN probably figured they had nothing to lose.
On March 16, the FDA revised its guidance, that opened the door wider and included companies like DECN. A pre-EUA step was added to the guidance which also allowed for kits to be sold (government calls it distributed) to entities that offer professional services by professional or semi-professional people under the management of professionals. Pharmacy assistants could administer a kit to walk-in or to parking lot clientel. The med tech who draws blood in a laboratory drawing station are now qualified -- at least the drawing station is. And, home health professionals (visiting angels etc) could administer kits. DECN's kit forecast is based on this change in guidance.
There are more than several coronavirus test kit contenders who saw their stocks run up and up, and raised tens of millions in equity capital who in another era would be called frauds.
But, the new EUA does not allow for direct sale (distribution) of kits to individuals through mail order, retail sale or places like Amazon. That comes later.
No matter what the people who know it all or the naysayers, or the BDS people tell you, DECN is in a great space. Mr. Berman is in the kit manufacturing and distribution business. Several here and many on the iHub board want him to be in the stock price engineering business and want him to go balls to the wall for an FDA pre-EUA, and do anything or say anything to achieve this. Mr. Berman, however, is in this for the long haul -- he has a technology business to run.
He is more interested, in fact laser focused, on the market and for doing good for humanity, and he believes the stock price will follow. Others don't care. Nonetheless, Mr. Berman is CEO and has the authority to make these calls. Naysayers, know-it-alls, and people with BDS do not have this right, unless they step up and take over the company.
By the way, Trump may not have had a hand in all of the national engineering details of this epic battle against the invisible enemy, but he will be rewarded with both a second term and a great place in history for marshaling the resources in the US. What Mr. Berman is enduring is a microcosm of what Trump has to endure. Both will be big winners.
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