You make a good point that I was meaning to make but didn't get around to jnajay. While I'm optimistic about HART chances, I'm not betting the house on it. If this doesn't work out and goes to zero I'm not going to be happy about it but I won't be devastated either.
Everybody has different tolerances for risk and like you I have no problem with someone who doesn't see the need to take a risk on HART. I'm not sure why these people feel the need to insult those who are willing to take the risk.
I could tell tales about my successes and failure however I happen to have a long term public record in TMF's stock picking competition CAPS, under a different alias MKArch. I've been in the competition since 2006 and I'm well into the top 1%. My key to success has been a willingness to take risk when I think the market has it wrong. In CAPS I've had to rely on being more right than wrong and bailing when appropriate (CAPS scoring makes the decision to bail a little trickier then real life). In real life I can also weight my picks.
I'm quite sure a few years ago when selling supplies was supposed to be the business plan they were still going to get FDA approval for the overall treatment it was just a matter of different assumptions at the time as to who would be responsible for growing the regenerated trachea. In recent calls management explained that the FDA specifically required that HART act as the single source so that they could control the conditions the tracheas are grown under. Thus their current business plan is substantially different than what they described in the registration statement for the proposed IPO a few years ago. This might also explain why their CEO stepped down from the same role at HBIO the company he founded and put his own money into HART even after the failed IPO. Either than or he's just a glutton for punishment.
Jeez test you're all over the place. First you were ecstatic that you discovered longs were idiots and didn't even know HART was only selling supplies and the doctors did all the hard work, except you were wrong. Now it's the FDA rejected the crux of their business plan, except that in requiring HART be the single source of the regenerated tracheas under controlled conditions, they increased the revenue potential by orders of magnitude. Boy the FDA really screwed HART good. I guess that's why the CEO stepped down from the same position at HBIO, the company he founded, and took HART's CEO position in addition to investing a significant amount of his own money in HART.
BTW te_st, you may recall you spent a half a day or so claiming proof that longs here did no dd and didn't even realize that HART was not selling a regenerated trachea they were only selling the scaffold and bioreactor for the doctors use in growing regenerated tracheas. Recall also this was based on information you read in the registration statements for the failed IPO's that you later discovered is no longer the case and HART is not only selling the regenerated trachea's, the FDA is mandating that only HART can regenerate the tracheas.
Not only were you completely wrong about who didn't do their dd and what HART's model actually is, but you compound it again citing the "failed IPO" for a completely different business model than HART is currently pursuing as proof they'll never be able to raise additional funding. They were proposing to sell a plastic tube and piece of equipment the size of a toaster when they were trying to IPO. As you were forced to admit they're current business model is completely different now.
I asked for specific apples to apples examples of certain death prognosis and at least 20+ months average survival. You told me it's too much trouble I should just trust you. In regard to financing, as I've mentioned before I've seen pure garbage no real business get funding through convertible debt that only relies on the holders ability to game their discount to the market price. You ain't scaring me with the financing angle.
In regard to Dr. M, I'm the one who first brought it up on this m.b. and have said repeatedly he bothers me and I'd like to see them move on from him. That said here's some relevant information from the call:
"Secondly, we would like to address some recent press reports publicizing allegations of ethical misconduct by
Professor Macchiarini in his work at the Karolinska Institute in Sweden. Please note that none of these allegations are made against HART and none concern the Russian clinical studies mentioned above.
These allegations are currently being investigated by the administration at the Karolinska Institute and we take no position on the outcome. However, I would like to point out that of the three patient cases mentioned in the allegations, only one used our scaffold. The other two surgeries used earlier generation scaffolds not made by HART.
Both those two patients who had not received HART scaffolds have died. The third patient, who did receive our scaffold, was previously implanted with an earlier generation scaffold that was removed and replaced with ours.This patient is alive more than two years after the original transplant and more than a year after being implanted with our scaffold."
In fairness, given Russia is a developing country, if it turns out that allegations against Dr. M in Sweden hold water his work in Russia is going to be suspect even if no official complaints are filed there. Since the allegations involve the quality of the recovery, not the survival time, and seem to involve mostly cadabre scaffolds, not HART's proprietary spun plastic scaffold, I don't believe this will invalidate the proof of concept. It will weaken it if proven true. If he faked everything it's game over.
It's getting hard to keep track of posts in the last thread so I'm starting a new one. To address a couple of allegations against me, I never said FDA approval is a done deal, I've always held out the possibility this doesn't get approved. Te_st on the other hand has admitted his opinion is set in stone, and no one can tell him anything that will change his mind. I'm actually giving him a chance to tell me something I don't know, however so far it's exactly what he accuses me of falling for "anecdotal evidence". There's lot of companies that don't get FDA approval including the largest pharmaceuticals so HART won't either.
Just to clarify a point; anecdotal evidence is a couple of examples out of a large population. HART"s compassionate care cases are not anecdotal (IE: 6 cases out of 1000) they are however a small enough sample that it's possible results may not be typical of a larger sample like the 30 patients in the clinical trials. The compassionate care cases did happen the results (unless faked) are way beyond coincidental. The fact they were not done as part of an official clinical trial doesn't mean this evidence doesn't exist and can' be used to guide a decision about HART's chances of approval.
In regard to companies that have failed to get approvals, while I haven't invested in any, I've looked into the hype about "promising" results from time to time to see if they warranted thinking about. I've been underwhelmed by 10% better than control for non life threatening conditions with alternatives already available. Or researchers found something that "attaches" to cancer cells, so they are hopeful they will eventually find a way to modify it into something that kills cancer cells. In other words the "promising" and "hopeful" results are not based on actual patients with a couple of months to live, surviving 20+ months on average and growing. It's much less tangible evidence and completely different situations.
O.K. show me the cancer treatment where the patients treated and the target population had a prognosis of a couple of months to live, exhausted all other alternatives, survived an average of 20+ months during trials and the product didn't get approval.
I'm familiar with promising results in lab rats but didn't quite work out in humans. I'm familiar with early trials showed modest results but with plenty of already approved alternatives so we're gonna put this one through the ringer before approving it. Give me an apples to apples comparison of near certain death sentence and results uniformly way beyond coincidence.
"seemed to succeed in 1000s of patients during extended trials"
Define "seemed to succeed". Talk about anecdotal evidence how about any evidence other than you said so? Show me a company who's product resulted in patients with a life expectancy of a couple of months, who exhausted traditional treatment, living for 20+ months on average that didn't get approved?
Just to clarify my point, I'm not claiming it's a done deal HART's as good as approved, I just want to see you come up with an apples to apples actual comparison. Show me a company treating patients with a certain death sentence, living 20+ months and way past their prognosis without the new treatment that didn't get approved.
I don't need hyperbole about the hundreds of billions of investor losses give me real life apples to apples comparisons of certain death prognosis and actual results far exceeding expectation under traditional care that didn't ultimately get approved.
I've followed plenty of b.s. companies and outright frauds for entertainment and more often than not I'm the bad guy on the message boards because these companies are more fun to debate. You don't need to lecture me on overly promotional b.s. businesses looking to scam investors. If you visit the S.A. articles on ChiScam: NQ Mobile (NQ) you'll see me all over the comments sections of the articles as the bad guy.
There's a huge difference between "we think our wonder drug will cure cancer" with zero basis for the claim and we actually treated 6-9 patients (depending on whether you count the bioreactor only patients) under compassionate care, all with life expectancies of just a couple of months with the average lifespan 20+ months and none dying of causes related to the scaffold to far.
It's possible they are lying about the results and unfortunately with the accusations against Dr. M there is some possibility that at least some of the claims about the robustness of the recovery may be in question, however outside of a massive fraud in the reported results, the product has proven to be substantially more effective than traditional treatment in the compassionate care cases to date.
You had your chance yesterday you could have taken your shot at attacking any claims you thought were unrealistic. Unfortunately I have a severe fear of public speaking and couldn't spit my questions our coherently and follow up but I took a shot at getting them to address your concern that their expectations are baseless. They did a good job explaining the process and all you have is some other company you follow didn't get approval so HART won't either. I'm open to critical debate but telling me that other companies in the regenerative medicine space have been unsuccessful so none will ever be doesn't persuade me. If you really want to convince investors on this m.b. you should have made your point on the cc yesterday.
I'm not in the medical field so I didn't know exactly what you were getting at when you brought up the large animal studies, however between the call yesterday and getting a chance to listen to the archived Q3 cc this one is no big deal. To begin with it's just the U.S. FDA approval, it's not required by the E.U. approval process. Second it's apparently standard procedure for they approval their seeking and third it's only adding 6 months to the U.S. process.
Per the call yesterday they expect to begin EU clinical trials about mid 2015 and U.S. trials at the end of 2015. They specifically cited the requirement for large animal trials in the U.S. as the reason for needing the extra 6 months to begin clinical trials. The 2017 projection for approvals always anticipated the large animal studies although it might be anticipating just the EU at first?
In regard to chances of success at large animal and clinical patient levels even though there is reason to be concerned about the veracity of some of the data, the prognosis of a few months without the regenerated trachea and surviving an average of 20 months and growing does not appear to be in question. The quality of the recovery (in some patients) may or may not be as robust as reported, however all of the patients significantly outlived their prognosis without HART's trachea. There's enough proof of concept in the compassionate care cases even accounting for questions raised to be optimistic that their regenerated trachea will do significantly better than traditional treatment.
Do you have information on who performed the compassionate care cases, where and results? I just noticed the scripted remarks were published in the 8K, so I finally had a chance to go back over the remarks about Dr. M. and Russia. I'd feel better if I knew we had a few successes that had nothing to do with Dr. M or Russia. It sounds like I might have to settle for Outside of Russia but not questioned, however I'd really like to see results with both out of the picture.
I'm assuming the replay will be a webcast however it's still missing from their web site. On the bright side I don't remember earnings calls being available for replay on their website but ran across Q3-14 which I missed the original call.
Reading the articles, it sounded like this might have involved the patients HART counts in their compassionate care cases which scares me. However if I heard correctly, I think they stated that was not the case. No 8K filing or press release about this leads me to believe HART's compassionate care cases are not in question.
Ideally Dr. M is exonerated. As long as any issues don't impact the results of HART's compassionate care cases I'll breathe a sigh of relief. Even the accusations don't seem to contradict the survival time just the quality of the recovery and survival. Regardless I'd like to see HART move on from Dr. M or at least spread the load around. Actually I'd like to see a clean break with Dr. M.
This one was news to me. Looking up articles regarding allegations against him bother me, particularly as there were already issues with him regarding taxes in Italy. I had no clue about this prior to the call so I wasn't prepared for management's response, although it sounded like the issues did not relate to any of the patients they cite for compassionate care. The fact he's been accused before and no problems were found and one of his current accusers apparently has an ax to grind somewhat offsets the accusations however they bother me. It looks like there will be a replay of the call on the company web site so I'll listen again before making full judgment however this is troubling.
Yes they' all make their best pitch and the failed one's will have oversold their opportunities. You seem convinced that HART has little chance of any approval let alone expedited approval and a low hurdle. I say this sincerely, call them out on it if you are convinced this is not the case.
It sounds like they might be taking calls from investors (or skeptics), if so, why don't you call them out on what ever you feel like they are over stating or not addressing?
Since I'm not big on public speaking I emailed questions in hoping they address them in the scripted remarks. I sign up for questions if allowed just in case.
I'll be listening and I have some questions ready if they take them from investors. I liked the idea at first, then worried they were going to drop some bad news this morning that the call was really for. So far it looks like it's just to calm nerves after a pretty good beating on no particular news. Hopefully that's all it is.
Disregarding whether the net cash position is real or not, when you have no claim on the cash due to the VIE structure, it's worthless. IE: even if the net cash position were real, and NQ was liquidated, U.S. investors wouldn't see a penny of that cash.
We actually didn't have a conversation yesterday and your explanation is still pure gibberish. U.S. tax code has zero, zip, zilch, nada implications for a Chinese business with no operations in the U.S. except a sock puppet manager and insignificant office space to support the sock puppet, selling a Chinese subsidiary to another Chinese company in exchange for a controlling interest in the acquirer. NQ is already a China domiciled business they don't need to worry about U.S. corporate taxes. The only U.S. tax implications are the shareholders losses they get to use to offset gains elsewhere.