Why don't they have either a button on top and bottom of the dispenser that need to be pressed down by one's lips or either a heat sensor on top and bottom that would detect the warmth of one's lips? Wouldn't that easily cut down on possible tabs not being delivered effectively? Of course, I am not probably really educated on the issues surrounding the problems with the CRL.
Can anyone inform me of the current features they have in place that would prevent one from "accidentally" dispensing a tablet and having it not fall into the mouth?
As much money as they are dishing out, they should take it over and rid this company of whatever apparent mishaps they are making. They could make a low ball offer for the company and get the company at a premium price.
Didn't Ram and his colleagues say write that they felt ACRX was worth $40 upon approval? Pretty sure I read that. Just can't find it. How do they come up with such a high value? I can't imagine a scenario where it would jump that high. I would love $20 and then climb from there. Long holder.
I realize your objective here and also know that there have been many pain killer rejections. I can't find one, ONE, however, that was rejected by the FDA that passed 3 successful phase 3 trials and is being administered only in the hospital setting. If you can find one, please pass it along as I would like to review it. As with any drug, it carries risk, but this drug has many benefits. My cousin, God bless him, was pretty much euthanized with a dose of morphiene as he gasped for air in his hospital bed suffering from cancer. The oxygen deprivation that morphiene has makes that possible and very real. Zalviso's effect on oxygen is apples and oranges. In the end, this drug provides a very good alternative, especially when you consider ACRX-04.
That positive benefit here can not be understated. To have a person who has already seen the approval of "almost" an identical drug and who can provide all of the information needed not only for FDA approval, but also to help the trials show data that could demonstrate Plecanatide's superiority over Linzness, is HUGE!
Aany, though I would love the PT you gave, I just see this getting bought out much much cheaper. I could see $15.
I am heavily invested in this, but I am not sure a B.O is going to take place this year. I would have to think that at least 1 Phase III would have to come back, which is late in the year, for there to be any consideration. I hope I am wrong.
Yes, but why talk about Sp-333? What new information does Linzess have that we couldn't have still shared information regarding our Phase IIB results in almost 1,000 people and then just prefaced that it has also done well in it's first phase IIb results in IBS with similar results? Not arguing, I just don't understand why? I would think that Plecanatide would make a bigger splash since it is in later trials.
One thing that would get,the momentum going is if in the quarterly update, there is discussion regarding big pharma companies interested in SGYP. I have to think that questions and focus will start to key in on that discussion.
To the previous large Phase IIb CIC results with about a 9% rate of diarrhea. I am curious how similar the phase III results will be, also. I don't think we find out anything new, just confirmation. It seems patience is our only real obstacle.
Did you read the PR on Synergy's website? Yes, it talked about placebo rates. Also, the only thing you need to concern yourself with is "statistically significant when compared to placebo."
Can't remember what article it was, but a former guy on Wall Street wrote recently how manipulated the market is. Talked about how companies like BOFA went over 200 trading days without losing in the market. He talked about how impossible that is without severely interfering with the markets. It's just not a fair game by any means.
As the price a year out or several months from now will be nice.
$60 million in 1 qtr. That is nice to see. I think this bodes very well for Synergy. Like many have said, I think IRWD is doing a lot of the heavy lifting here and will make it even more cost effective when we enter the market.
That was a key word I focused on, also. I guess one could view that both ways, however. I just think it would be very abnormal for the company to start another phase III so quickly if the previous one did not meet the endpoints. I would think there would be some further discussions within the company and with the FDA on how they wanted to proceed.
Try not to use too big of words in your vocabulary that you don't know how to spell. Kind of a rule to live by. It's spelled fascinating.
Come on! You can do it!