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Norchi didn't make any official press releases to that effect. He allegedly told Dr KSS that. Legally speaking, I believe that is called "hearsay" and Norchi is not accountable for that.
Officially, Norchi hasn't said anything. We are on our own.
There is probably a reason he hasn't released any information, and I don't think it's good. I've heard some things being batted around, but I cannot find any definitive information.
I'm afraid the reason for the silence is probably pretty serious. Norchi probably wouldn't sit idly by without a PR if it was something simple. So far, all we have is hearsay, hearsay that he said "delay us 2 quarters". Officially he hasn't said anything, he is letting others pass rumors along. I suspect it will be a lot worse than we are lead to believe by unaccountable people.
Norchi is out of his element. He has already hosed EMA and FDA approval, and our investments with it. I'm still up because I bought in so low, but I'm getting nervous, and his silence isn't helping.
If you've been in three years, you are still up. Time to sell your shares, the writing in on the wall. Nothing but trouble from here on out.
Sell your shares.
They will, but they have to get it in writing first. Any CEO in a position to have an effect on other peoples money has to be deliberate. He can't just throw something out there to shut up a bunch of idiot retail investors. He has to make sure, and the only way to be sure is to have it in writing in front of him.
You would probably be better off getting out of ARTH completely.
As for a partner, recent events make cause Norchi to be a little less picky, and take an offer he might not have 2 months ago. He's going to need money for the new study, he is going to have to wait longer for the external approval to help raise that money, and he likes to go to the ATM well in advance of running out of cash.
For those of you who sold, thanks for the shares.
Or it could just be that the FDA drug it's feet for 89 days, then the day before making a decision, they asked for data that could not be compiled in 1 day. It was then up to Norchi to either get the application put on hold for 180 days, or pull the application, compile the data, the start the approval process again. The process is supposed to take 90 days.
IOW, it might just be that Norchi didn't lie to Dr KSS.
I suspect there may have been a little "off the record", but until Norchi gets the FDA response in writing, we'll just have to guess.
Dr KSS said in his article that the three areas the requests did not involve were AC5 being a device, the facts and data contained within the large biocompatibility package submission, and the data from the Irish clinical trial and will not require further study.
That leaves manufacturing.
Sgt Schultz would say "I know nothing". "Very, very interesting" was Arte Johnson on Laugh In.
There is no disputing he is a bit of a disappointment, but the product has amazing potential. But doing what he has done isn't easy. Another company has a license for AC5 but it's restricted to IIRC GI use. They never even got a study completed.
On another board I frequent, this was actually expected. Members have been predicting a significant hit on the pps when the FDA had follow up questions, which they ALWAYS do.
People are soiling their undies and I cannot for the life of me understand why.
An order well under the current pps. If the current share price is .80, and you put in a buy order at .40 trying to pick up someones stop loss. It's very effective in small cap biotech like this because the nervous nellies run to the door at the slightest little thing, and when whomever is flash crashing the pps.
You say "glorified bandaid", and that is an immensely foolish thing to say. You apparently don't have a clue what this product will do. I know what it has the potential to be.
Nobody made you buy ARTH. Nobody is making you keep your shares. If you think so poorly about the product and it's management, you shouldn't have bought in to begin with. The people slamming Norchi are obviously exceptional individuals who could have done so much better themselves, but they are apparently not good judges of ability.
I haven't been in ARTH for 3 years. It's easy in hindsight to say you could have done better in the Dow, but when you bought into ARTH, you couldn't have known the market wouldn't have corrected by now. Idiot Mark Cuban predicted the market would tank when Trump got elected, and look how that turned out. You also don't know the Dow will not collapse between now and ARTH approval.
It's easy to forget the stink orders.
Don't assume the worst. I don't doubt that 2 weeks ago Norchi was confident and didn't see this coming. If he knew he had upcoming problems, he wouldn't have said that.
Sometimes things happen exactly like they are reported. If you don't trust Norchi, you shouldn't be invested in ARTH. If you trust Norchi, you should be patient.
Nobody has made a sucker out of you. If you sold, it's on YOU. You cannot blame anyone but yourself.
What has happened, is the people with deep pockets, the ones who have been flash crashing this stock for the last few weeks and are buying today, know typical retail investor behavior. They were ready for a buying opportunity. They supposedly know when there are stop loss orders and at what price, and they know when anything shakes the tree, Chicken Little starts running. It's a safe bet they know the process better than I do.
From their perspective, it was a likely scenario, considering how few small biotechs get approval the first round.
I don't know. If so, I would think there is something in the letter of the law that requires ARTH to have "all the data in" by a certain day, or within 1 month to the last day. I really don't know, and didn't mean to imply I did. But we will find out. What I do know, is I've never been in a small cap biotech that didn't have gut checks throughout the entire process.
I trust the product. I don't see why Norchi would lie about it, knowing the truth will be a matter of public record at some point. Saying that when it isn't true could even be illegal as releasing incorrect info with the intention of helping the stock price. I don't think Norchi wants any of that.
Sometimes, believe it or not, people actually tell the truth.
One thing is certain: Someone has bought several million shares today at .50, and group think is generally accepted as being more accurate. I doubt a couple retail investors have that kind of cash, so somebody with the money believes there is a potential profit.
Take your ball and go home. Biotech investing is hard on the nerves with multiple gut checks, but the potential upside is huge. If you don't believe in the product, and don't have the nerve to sit out the pitfalls, then sell your positions and get into an index fund. I don't remember any biotech I've been in that didn't have pitfalls, and most of them caused by the FDA and the written letter of the law they have to follow.
Retails with stop loss orders are losing their positions.
Norchi told Dr KSS that he had 1 day to answer the question. I see no reason to doubt what Norchi said.
We retails often forget our stink orders.
Come on folks, enough with the whiny butt-hurt. Wait and see what the concerns were and how they will be addressed. It could still be a very insignificant issue.
These things take time, and very few CEO can perfectly navigate the choppy waters of the feral (my spelling) bureaucracy. Congress wrote the law, and the FDA and any applicant is hamstrung by the law.
I suspect it was pull the application of get a rejection. Which would you prefer? The device equivalent to a CRL, or pull it and resubmit?
In Dr KSS' article, he states that Norchi said there wasn't a problem with the Class as a device, the facts and data of the submission are not in dispute, nor the data from the study. KSS calls these "three cardinal areas:
I suspect the 1 day response was limited by the process already being several months old.
Norchi saying he still expects approval in 2018 makes me think it's insignificant. He is waiting for the written response from the FDA before he goes any further.
I don't think this was a death blow, and there was recently a time when I was tickled to see .50 share price.
Norchi told Dr KSS he had one day to reply to what the FDA needed, so he pulled the application.
So will they be icing the wings for a full month?
Monday is the 5 month mark, so just one month left to go. That is, IF the FDA is REQUIRED by law to render a decision in that timer frame, and IF the 3-6 time frame is 6 calendar months, and not actual business days. The FDA can be very creative in finding ways to allow the bureaucrats to sleep a few more days, and drag it out.
I think the instigator is just trying to stir stuff up. Retail investors are like a bunch of whiny little girls, and I suspect he has a devious side that likes getting them butthurt and worried.
5 months would be early for government bureaucrats. They don't seem to like doing anything until they have to. The way I envision it, some bureaucrat is sitting at his desk on January 17. His calendar throws a popup reminding him that tomorrow is the 180 day mark, so he throws a couple check marks and signature on a form, and puts them by the fax machine marked "Fax on January 18" and that is the form Norchi will receive. Being a bureaucrat, as soon as he finishes working on ARTH, he has to take on another case. As long as he is nursing ARTH, he doesn't have to do anything else.
Here's one for you: The FDA has been averaging 120 days this year. 4 months. That would have been November, so theoretically, we could get news just any day, but bureaucrats like what little power they have to mess with the lives of others.
It's a safe bet we won't get the word until January 18. IF the FDA must by law, if not, even that date isn't solid. The FDA doesn't seem to get in any hurry, there are a lot of holidays in that 3-6 Months, and ARTH doesn't have any leverage.
So we wait.
I don't remember ever watching a small cap biotech that actually got a result from the FDA early.
The Presentation last week specifically states the 3-6 Month time frame from submission "remains in tact
*Received and responded to clarifying questions from FDA, as expected
Expected timing for FDA response remains intact: 3 - 6 months from recent filing