Micro & J20, how exactly you suggest to protect the borders?
IMO, we need to prevent illegals from working here, then they simply won't come!
My-self being an immigrant (twice actually), but long time ago (28 years ago) I very well understand both sides here....Maybe we should take example from Canada, they've point system and not that many people can get in...However, we've too many illegal immigrants and there is no way to prevent it from happening besides more tight border control, which I'm not if possible.
At this point we've 12mil illegals; we can't get rid of them so we've 2 choices: to grant amnesty and to try to incorporate them in our "legal" society or to keep them illegal and out of system. What do you think is better solution?
If we wanted to control the situation, we need to put heavy fines on every employer that hire illegals, including jail term and to send home every one we catch...However, the political climate here will never allow for such things...BTW, this is what done in Singapore. And the system works fine there....
MBB, I agree that risk profile of CLDX has changed, but not because of 42% price drop, but, rather, inexperience of management. However, the important point is that chances on success had not changed,- there is no new fundamental information that has changed that. So, while it became clear that path to approval will be not that easy as expected it has not change the probability of approval. Also, the problem with trading is that you always take a risk to miss something: big move, buyout offer etc. Therefore I'll stick to my position for long time, until everything good that supposed to happen to CLDX will happen.
1. The power to predict short term price fluctuation based upon market sentiments is not different now then in the past.
2. The chances of success did not change as function of total regulatory failure of the management to foresee it.
So, I'm also holding until all great things unfold- Rintega, Varli, Glemba,- long term holders eventually will be rewarded.
MBB, what J20 means is that usually investor can't predict the price fluctuation of the stock and invest based upon fundamentals. In this case the fundamentals point to potential of, let say, $50, so selling before CLDX reach that price means betting on opportunity to enter at lower price. Of course, knowing everything now, it would be good to make numerous rounds with "buying low-selling high", but this possible in theory only, so if were able to do so- power to you! The rest of us, without such great prediction abilities, rather wait whatever it takes to get to $50+ and only after that will decide about selling or holding.
The only thing that could be held against AM is not hiring right people able to understand and deal with FDA. Instead he solely relied on science. And the science so far was really good. If it continue to be as good as it was, then we all (long) will make a lot of money. If not...well, there nothing guaranteed about p3...
The s/p goes down because investors start realizing (from sober tone of CC) that approval not going to be walk in the park, but requires to jump thru few loops and AM (looks like) did not expect it....However, change in the mood will happen again when we get some positive news (Varli trial results? another publication, conference..., new bull in bios...who knows what?) and whenever it happens we'll ride back to $30's+ again. Until then- need to sit tight and wait.
Share, look at ONXX: they've 62 people trial size (if I'm not mistaken) and got approval based on p2...
My suggestion to all longs:try to see the big picture: keep in mind that latest setback was pure regulatory or/and managerial, and has nothing to do with trial results (that were really solid) and expected to be not less solid in the future, and lead to approval- sooner or later!
Sentiment: Strong Buy
Whip, CLDX management team seems very inexperienced in deal with regulatory matters- the results of ReACT were statistically significant, so the claim by FDA (probably in informal conversation) that results maybe "a fluke" due to small trial size is total garbage and if CLDX people had more balls, experience and the right regulatory savvy team, they'd submit ReAct for approval and then we'd see how FDA would argue against statistical significance of numbers...
But they're cowards and afraid to spooke "800 pound gorilla" just in case...
Ray, taking stand on abortion issues turn off women and being tough on imigration #$%$ minorities. So, being true to Tea Party values and/or conservative right definetly not going to win election...
Frank, our GOP friends are went too right and allienated almost everybody- women, Spanishes, and everybody in the center.
So, I hope they've learned the lesson and let more moderate candidate to run and win. Otherwise we'll be in opposition for another 30 years
Db, Medicaid & Medicare already in place and functioning! So, the range of their activities could be seriously increased under one payer system. They're managing so far, so there are chance they'll be able to handle it
Frank, Hillary is our best bet to win White House back, but it is not going to be Trump- he is there only for him-self, not because of any ideology and Ben Carlson seems to be much better candidacy (but, of course anyone would be better than another 4 years of Democrat)
While not disagree with you regarding "government and our money" issue, the current (and previous) system are totally broken,- the inability of patient to keep lead on medical expenses, million conditions for what when covered and constantly changing list of MD's in and out of network, all these problems would be resolved with one payer system. The insurance lobby and trial lawyers are the reason for the mess (but, hey, have ever met one honest lawyer? or contractor?)
and, while being republican, I think in that (and abortion issue) our GOP dropped the ball
Scr, I fully agree with you and even can add that hiring people dealing with Rintega distribution after (potential) approval is also publicity stunt- there are few thousands on salary at risk, but - this person could be fired any moment if things do not go the way expected, but otherwise supposed to show the trust management put into future of Rintega.
However, with or without all these PR moves, looking at the bigger picture we need to acknowledge that so far the science was the strong suit of CLDX (unlike regulatory matters)
and as long as trials produce solid results the s/p will react accordingly. the current situation is just bump in the road, not the first one and, unfortunatelly, probably not the last one...but eventually longs will be rewarded (despite regulatory uncompitience of current management...)
I'm not sure where this number came up from, but so far in the last 4 years the cost of insurance almost doubled and in NY for the gold coverage on the exchange with "normal" company one need to pay close to $600 for single and $1600 for the family.So, it is great to have standartized policies for just price comparison, but a lot of doctors were "fired" from the networks and with this prices not that much people can afford them...
The whole thing would worth it, have we implemented "single payer system"- the medicare coverage is much 1/3 cheaper and paperwork would be greatly reduced!
While I'd like it to be the reason, there are some other things we need to consider:
1.Varli was in p1 trial that usually not powered to show statistically significant efficacy, so I do not hold my breath...
2. BMY's drug is pretty effective on its own, which means that it should take some time so the effect of Varli addition will be seen and this need to be longer than current trial ongoing, so I'm VERY curious what AM so exited about...
3. BMY need to see really spectacular results in order make a bid for CLDX.
4. If and when it happens they'll offer 5B.
My main hope that trial with Roche produce not less spectacular results and we'll get from them really good offer...But it will take some more time, so for now, lets hope the next ACT IV DMB reading will be really positive and trial will be stopped early...
Whip, for unexperienced CLDX team with regulatory issues, to prepare submission based upon ReACT, will take more time than to get results from ACTIV, so it is simply not time +resources allocation smart and wasteful..It seems that they've expected it will be walk in the park and approval will come without any formal submission, just based on scientific results and enthusiasm of community (patients & doctors). Now, they're learning that things are not that simple, and what they should do now is to hire somebody really familiar and experienced in that side of business so submission will go thru flawlessly. I'd suggest someone from ONXX- they've got approval based on p2 and 62 patients ...