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Per Jim Stern (6/18/2020 @ 11:40AM):
Yeah, you're slightly mixing terms.. but many are. EUA is the main list, but the FDA is not stopping distribution by manufacturers of kits who have applied for the EUA and have passed initial vetting (the list dablood is on). There is no approval being granted.
We're not on the current EUA list, but so are nearly no others since the latest rule change requiring independent testing. Those are just now starting to leak out, albeit slowly.
Also worth noting that all currently released are still required to be performed in a certified lab or with special equipment, requirements which we are not holding. Logical that we would require extra due diligence before EUA.
IMO, the FDA has the lionshare ownership of the blame for lack of EUA, whereas PRED has missed on communication to shareholders. Tough to play Monday morning quarterback with all of the changes though, so just hoping we see something soon and kill the conversation.
Where's the specific text stating the white list/guidance supersedes and cancels prior
export registration/approvals?
I can't prove text doesn't exist, only require proof that it does. Nothing in SAMR or NMPA policy I can find.. so please share if you think it exists.
Edit: I looked through your post history since the white list went into effect and can't find any links or text stating.
Is there a government policy update/doc that explicitly states this? Please link.
Correct regarding the white list, incorrect regarding export ability to the states. Please see the previous export certification document posted.
Shipyard white list has nothing to do with the COVID white list published by the SAMR.
Ah, thx. So few things:
1. IgG/IgM is split. Generally assume you'll have to double the cost for a joint kit (yes common pack, but likely a lower volume assembly and more injection mold mat.).
2. These are the base kits with no further modification (English language, unique processing, alternate manuals/instructions, etc), which I would expect further markup.
3. Factor in logistics costs to get here... Pred isn't (nor would anyone doing similar) pay $3/test.
But very good info, will help verify a bit and this is the type of stuff I'm glad to see.
Use a free site like imgur then, takes a minute to figure out.
And disagree (coming from a field as well of dealing with CN product development/purchasing and receiving free and or severely discounted samples). Depends on the approach, use, and sales environment. But who cares, we can argue till we're blue in the face before we even go down the route of how much capacity pred may or may not have contracted, profitable markup structure, etc. Just show some photos.
Ah great, please post a pic showing them.
Also assume sample quantity. Speaking of which, I had a free bite of frozen chicken a while ago at Costco. Can't believe people buy a whole chicken for infinitely times what I paid.
Damn guys, we've got a manilla folder. Serious business over here.
Ah, good point. Still, I would absolutely consider the following an "approval" letter, although if one wanted to argue semantics... sure, it's not. But I wouldn't fault any in casually calling it one.
https://www.sec.gov/Archives/edgar/data/1382943/000000000019009260/filename1.pdf
I would also point to other letters on Merle's tickers, but those are unrelated tickers to PRED.
Yes and no. Form 10s (specifically 10-12Gs) are absolutely reviewed and cleared by the SEC. There are generally multiple rounds of comments/amendments well over 60 days, and the SEC on the last revision will typically issue a correspondence with no further comment prior to the 60 day period (review closure).
PRED's own filing history for example:
12-06-2018: Initial 10-12G filing
01-29-2019: SEC upload, comment letter
04-22-2019: 10-12G/A filing
05-17-2019: SEC upload, comment letter
05-22-2019: 10-12G/A filing
06-03-2019: SEC upload, letter on review completion.
There may be some system that automatically updates status as of the 60-day mark, but I have never seen it... please feel free to show an example.
Regardless, if Merle was able to get a no further comment letter in < 3 weeks on an initial 10-12G filing, that is nothing to scoff at, and getting tripped up in approval language is not the point.
Wrong. Time will tell.
I did speak with Sapphire, and she did mention Predictive Labs when I inquired on US distribution status. I can post the conversation later. But again, sounds like you're not trusting the company... except for when you do (and then can't back it up).
Vice President of what? Marketing? HR? Please post their info and I will contact as well. But the Dablood parties (sales) I and many others here have discussed with on LinkedIn are very familiar with Predictive Labs.
And I've also got a contact that says the company is in daily discussions with Elvis. Good to know contacts always have 100% credibility and we should not trust posted company reports...
You also say you have recorded phone conversations, please feel free to post those as well if they are evidence that you wish to convince people with.
Wellgistics paid PRED as a part of their agreement toward tests. Funds for which PRED stated are needed for ongoing test purchase. Doesn't matter though, the only real data point we need is test arrival/EUA.. nothing else IMO.
Key point of the document is, much of this board has been stating that tests can not be exported. Documentation from the CN government was shown tonight that says otherwise. If people believe tests can't come... that no longer has any backing (until someone claims "photoshopz!!1!").
Thanks, no surprises I can see.. let's see if the company issues a joint press release on Monday.
Definitely Innovita's test kit/box.
https://p.globalsources.com/IMAGES/PDT/BIG/245/B1175660245.jpg
Yep, agree. I'm just bored and love running down rabbit holes.
I'm pretty darn confident as well that PRED will see a large amounts of tests here in the states in days time. There are of course concerns on a lot of fronts, but for every concern there seems to be a handful of alternate paths. We've hashed through them, but many continue to keep ignoring.. it's almost like some are blatantly ignoring any positive potentials. What's that old saying, "an ignore for an ignore"? Lol
Yeah, my bet would be 0.5-1.00 per kit of extra cost for air-freight. But I can run a tool later with some packaging assumptions if anyone cares.
Pelco's theory is a good one. The plan may have been to do the first orders via air once the EUA hit and eventually be backfilled by ocean. Since EUA got delayed, there may be an ocean shipment incoming shortly.
If demand projection is 6+ months long, at some point they may want to move to Ocean shipments to reduce cost, but would do both air and sea until that happens.
But who knows... demand may be so astronomical and risky that they may hold off on ocean all together. Cost/unit and pack density are both so high that air freight cost may be a drop in the bucket. Good thing we have a seasoned company such as Wellgistics to make the plan and not me.
Yes. No tests/EUA furthers the negative narrative. The moment either of those actualize is when the tide turns, and IMO... turns hard.
Lots of variables/contributions to price. Likely a mix of shorts, fearful longs, and day traders. I imagine there are many with play books being run, as the greys so far appear to be very easily manipulated. Likely why we saw a major jump in posters here as well.
Point is.. IMO short term.. Test come, longs win. Tests don't come, longs lose. All speculation will shortly be put to rest either way, concerns will be vindicated or confirmed.
Real question for those looking to buy/sell is what's the current risk reward at this level? I'm thinking it's a no-brainer.
Actual Study Completion Date: April 26, 2019
Interesting, wonder why the timing lagged so much to update the trial page. EDIT: https://clinicaltrials.gov/ct2/keydates/NCT03337243
I got the same. I have to remind myself that the initial announcement came out not that long ago, and for a new supply chain/product on expedite.. we're not too delayed if at all. I spent a while on the phone this morning with my DSV manager getting educated on timing.
But, I would be surprised if we have to wait until the end of the month, seems like they're trying to under promise and over deliver. Guess we'll see.
Congrats to those buying at this level. Tomorrow should be a fun pop.
Worth a reminder to all on how small of a % of the shares outstanding actively trades (meaning tons of large long holdings) in comparison to how many shares need to be covered by short sellers.
With no more shorting to manipulate selling.. good luck buying or covering at the low prices after the initial fear selling finishes and we start the ramp back up.
Anyone advocating for people to sell day 1 of greys is trying hard to cover or buy in cheap.
But hey, I'll take 0.25 shares if anyone wants to give them to me. Ooga Booga, PRED Bad.
BTW, I did call Wellgistics today. After getting a call back from someone closer to the antibody tests, I'm actually more positive on the overall status.
Thanks for the recommendation.
Someone's trying very hard to control the conversation. Company will continue to execute.. good luck to those looking to buy low tomorrow. First day typically sets the low and then rebounds over the following days.
Jiangsu Dabo Pharmaceutical (DaBlood) from CN is the original manufacturer of the test strips.
"Develop" can have a lot of connotations. Pred Developed the entire kit, packaging, labeling, supply-chain, and possibly some of the clinical results for FDA submission.
Pretend this is one long weekend since there is no trading. Why release news on a Saturday?
IMO, why wouldn't the company wait? We can't buy/sell anyway, and I'm sure they would like to come in hard with receipt of goods and/or EUA.. which is the ideal refute to the concern. If trading opens with nothing, then I could see concern. This time I agree with IR... patience.
Trading platforms are known to have errors like this. We showed on Nasdaq previously on a few for instance.
OTC markets marks it as grey:
https://www.otcmarkets.com/stock/WMGR/financials
0.25! Lol...
But realistically, first day will trade at 0.3-0.4, and rebound to 0.7 IMO the first week. Interested parties should watch SOLI, who likely was going to fall back to 0.35 without the suspension.
Regardless, first day selling is a losing endeavor, which is where those numbers have a shot.