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Any sign of the PRED purchase order for their packaging? Lol.. not everything hits an 8k.
Fully agree. Any idea that PRED is running a scam should have been killed long ago! Seems to be why the HB/related messaging has now shifted to concerns on financing/cash.
Might be worth clarifying for some. This is not the status of their test kit submission, but just the registration of their establishment. Per FDA site regarding registration:
Per yesterday's FDA release:
PRED does not have EUA authorization by the FDA as of today. EUA authorization is only granted upon review, although the FDA is currently not objecting to distribution to point-of-care and laboratories.
If the FDA reviews and does not authorize the EUA, the manufacturers are required to recall any product and suspend distribution. The EUA review submission is the pathway currently to full authorization status, and ultimately authorization for in-home use (no companies currently have this ability).
So to make things clear, there are currently zero holds on PRED's ability to distribute in the US to the necessary and high-demand facilities.
Cellex's EUA authorization in no way advantages Cellex outside of perceived legitimacy (non-risk of recall). That said, the tests are different and continuing to compare "winning" regarding a finger prick at X volume to a vein sample at Y volume is silly.
https://www.regulations.gov/document?D=FDA-2020-D-0987-0012
See Page 8, bullets 1&2. NO tests under EUA are "Approved", only authorized under EUA for specific use only. Media outlets and others have a high-level of misunderstanding (which doesn't matter too much), but overall the listed Company should never state this directly in their materials (also why Bodysphere saw backlash, not just in their other misunderstanding). All of PRED's documentation/messaging has been well within-line so far.
https://www.fda.gov/media/136622/download
Wondfo Board Member/Manager: Wu Shengling
- Director and General Manager, Wondfo Guangzhou Bioengineering Center
- Vice Chairman, Da'an Gene Co & Sun Yat-Sen University
- Chairman of Wondfo Supervisory Board
Per: http://static.cninfo.com.cn/finalpage/2020-03-31/1207429472.PDF
Chinese Approval information:
Latest CN Approval site:
http://english.nmpa.gov.cn/2020-04/03/c_468570.htm
While Da Gene does appear listed as PCR-specific.. please note the following:
Thanks, guru. Going to be a good week to those who ignore the other noise.
There will be a markup for SG&A and Profit- yes. Question is how much considering the scenario/demand/pack density/buyer. Not my specialty, but would think they would add 3-10% of total product cost (including expenses) for their profit.
Interesting read:
https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-hda-role-of-distributors-in-the-us-health-care-industry.pdf
PRED's can be done at point of care, which is all that is important given current demand right now. Healthcare facilities still need skilled/trained staff for venipuncture or centrifuging at a certified lab, which is a resource draw that is not ideal nor timely.
I would also not say that ability to perform via veinpicuture is close to being able to do via finger-prick. There comes a lot of clarity with venipuncture (higher quality sample) to rule out confounding variables that finger pricks can introduce. If Cellex's test has a lower sensitivity/specificity they may need veignipuncture or a large quantity to help. Likely a melt/repour to develop a test otherwise.
Yes, there is a whole blood test which does not require centrifuging, but that is through Venipuncture (needle-to-vein) and also required to perform in a certified lab.
Point is, none of the methods can be performed in a realistic/timely setting in high-volume for the Cellex test.
You could have at least tried reading it:
(edit: thanks for editing your post which stated there was no centrifugation while pointing to the FDA link w/ instructions. Holding to facts generally also comes with admitting when you're wrong. Thanks for showing true colors to all who have not yet seen).
Yes, I will be the first to say I never thought PRED would have or want anything to do with COVID-19. I was skeptical during much of the initial releases as to how valuable what they're doing will be.
But they have once again proven their flexibility to predict and react to market demands in an exceptional way. Good on the company for foreseeing, and hope it helps save lives and boost our pocketbooks!
Starting to show who the Real Losers are after a long wait!
Yes, which the plasma/serum needs to be centrifuged in a certified lab prior to application on the test kit.
To be clear, this is Assurance VR:
https://www.thermofisher.com/us/en/home/clinical/clinical-genomics/pathogen-detection-solutions/coronavirus-2019-ncov/genetic-analysis/taqpath-rt-pcr-covid-19-kit.html
"Predictive Laboratories’ viral test is labeled as the Assurance VR™ Viral
Test. The company intends to utilize the FDA EUA TaqPath RT-PCR
COVID-19, test distributed by Thermo Fisher, Inc."
That is the test PRED explicity calls out. Not a major "connecting dots".
Have you been reading this Board? The Cellex test is not a fast test given Lab run requirement. Very different.
The companies that are the farthest ahead are purely those that have been working longest. You can not throw billions at the problem and expedite the test kit manufacturing, etc.. just like Ventilators.
PRED seemingly got ahead of this long ago, whereas the other major players are newly reacting. That is primarily a function of revenue size in relation to overall business. It made sense for PRED to enter early, given what the ROI meant to them. The big players now have the choice to spend months to develop and qualify, or to partner with the early smaller guys. Makes sense, also why you see the same in other industries (e.g. GM with Cruise Automation).
As "the test" defines removing a new casette, I would believe repeating the test would therefore require a new cassette.
Thermo's test, run by PRED (likely other certified labs as well). IMO not a main revenue stream, but makes PRED a good one-stop-shop.
https://www.thermofisher.com/us/en/home/clinical/clinical-genomics/pathogen-detection-solutions/coronavirus-2019-ncov/genetic-analysis/taqpath-rt-pcr-covid-19-kit.html
Great read! FDA EUA very close.
There was a news post which had a photo of the boxes, which also linked to the site that was noted as removed. Any mention has been removed, so they don't appear to be selling or distributing the tests at this point.
Here's Brandon, the VP of the CN company who announced it if anyone wants to further contact to understand further.
Your #goals will become part of you if you review them every day for at least 60 days. pic.twitter.com/rXj1koTcn0
— Brandon Hensinger - Cima Growth Solutions (@BHensinger) April 3, 2020
I got a hold of a rep after multiple tries. Very professional, pursued from a corporate ordering perspective (even though they are not authorized to distribute in that capacity as of yet).
Was told to send an email with our quantities desired and company details when/if they have the capabilities to fill. But the rep did specifically note that all of their priority is currently with governments and hospitals directly, as to which demand is SIGNIFICANT.
So no surprise, but good to have reiterated.
Tried PRED's COVID-19 phone line 3x today... busy. Must be a very high demand/traffic.
Seems no further marketing needed to get sales.
He just spins his response wheel every time he posts. More regurgitation of the same nonsense.
I'm working out a good drinking game to pair with it.
Oh, Elk. Thank you for continually showing how poor any negative arguments are against PRED.
Cellex's test, as Pelco stated, is approved for use only by CLIA certified labs, and requires centrifuging. Really cuts down on potential customers and response time.
Good catch, interesting.
Assume so, appears to be a typo or reused page as I see no further mention, nor is Wondfo in the business. But the CE letters are there regardless.
Good point, also no proof that tomorrow will ever come either.
Very ignorant statements on both sides.
So his bio mentions PRED... must think that holds positive weight. Looks like we can put much of the overblown negative speculation to bed.
I'd agree, if the distribution for consumer buying is $50-250.. would think the average limit would fall around ~$150. Good thing that we're not selling direct to consumer, and likely these will be near given-away from large buyers to get economies running.
What we really need is a good example of use across the Globe for how these will be the most effective, to understand how many will be sold.
I've seen one example of a city testing all of the inhabitants, then a second time down the road as a confirmation. Ignoring global, if 20% of the US population follows that model, there is a need for ~130M tests. But I have to believe the limiting factor is the supplychain.. as obviously more and more local governments would want to adhere to the best-practices. So realistically I don't see much of an upper limit and would personally estimate the ~130M as the lower.
BUT PRED, out of all of the distributors, has so far noted the highest capacity numbers that I have seen. I would think a global sales of 50M is very realistic.. but I agree that time will tell.
Being as frugal as I am... what would I pay for a test? Upper-limit, $75. $50 profit is a no-brainer considering urgent need, lack of supply, normal medical profits/costs, and who is buying IMO.