I agree. I worry because these payers stifle innovation. However, no one can say existing therapies are adequate so they will have to pay.
Comments by Express Scripts today about Regeneron's and Amgen's drug for cholesterol are putting pressure on the stocks as price controls are likely coming.
What do you all make of the statement from Express Scripts. The same happened with Gilead. There will be pricing pressure/competition between the groups bringing these treatments to market
The endpoint was meaningless. Also, look at DHEA....it works through the same mechanism and was tried in Alzheimer's. Failed big time.
It just supports that Baxalta/CTI are actively advancing pacritinib into other indications as promised. I don't know when this will translate into a significant price movement as it looks like the powers that be are holding this in place. The trading range is pretty consistent.
Pacritinib Before Transplant for Myeloproliferative Neoplasms (MPN)
This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by M.D. Anderson Cancer Center
That posted before I was ready. My point #4 is that Baxalta has publicly stated that they believe that pacritinib could generate in excess of $6B in revenue. If this number is correct then CTIC is an extremely undervalued stock right now. It's so undervalued that Baxalta would have every single justification to acquire them as soon as possible. Having said this, Baxalta is currently listing on the NYSE and the stock will start to trade in early July. As such, i don't anticipate any huge corporate moves for the next few months. However, CTI has to be firmly in their sites if they are putting numbers of $6B+ in front of analysts. Pacritinib is core to Baxalta's strategy. That has to be making INCY investors (especially the biggest of them) very nervous.
I don't believe it's insider shorting. If they want to hurt the price they wouldn't have arranged for the $30M in milestones to come sooner than expected. They would simply raise a dilutive funding and that would hurt the share price. No announcement today hurt the price and if it did then someone definitely is struggling to understand the meaning of the Hercules extension.
I would argue that any shorting is due to hedge funds getting the price low enough so that they can accumulate shares at a good price.
Any one of the following potential events could drastically fuel an upward move by CTIC:
1. Breakthrough Therapy Designation (this could make it possible to file the NDA based on just Persist 1. The company hasn't said much about this but the strength of Persist 1 certainly raises the possibility of this.
2. NDA filing coming sooner than anticipated.
3. Positive Persist 2 readout.
4. Acquisition by Baxalta based on Baxalta's own $6B+
Hercules provides credit facilities/loans to companies that the company then pays back. It's a non-dilutive way of bringing in funds. I don't think any shareholders want to see CTIC do a dilutive fund raising event so this extension of the credit term and amount is seen as a positive.
Yes I am. That's my understanding anyway. If you read through the original loan terms it sounds like the extension also helps in terms of extending the interest only period. It's not the easiest reading but you can go to the 10k and see the original terms. This is the 3rd extension.
Eventually they must pay back the loan, but my understanding per their filings is that this extends the interest only portion which is good as it conserves their cash. This is just my understanding.
The reason is to do away with any near term cash obligations. The additional credit from Hercules also delays the interest only period for repayment which conserves CTI's cash position. This is just my understanding from their SEC filings, but to me it looks like a good deal to conserve the cash. One of the key things holding the stock price down has been the perception of a fund raise.
We may not love the way CTI is funding the story but the fact is that they're turning around a difficult situation and they seem to be executing very well. I do not mind the small amount of warrants to Hercules to extend the loan terms.
I would add one point to your message. There is a real possibility that the FDA could provide CTIC with breakthrough therapy designation and allow for an FDA filing with just Persist 1. The data is that good in my opinion. Things here could come together quickly. If you're really short then my recommendation is to close that position and go long. All just my opinion, but CTIC is starting to roll.
Yes, this is really excellent news. It does put to bed the concern regarding a surprise fund raising event. This was very well executed by CTIC. The removal of the fund raising pressure should relieve a lot of pressure from the stock. Very pleased
Baxter's Baxalta recently held an investor day type conference to discuss the future of Baxalta. They highlighted pacritinib extensively and discussed how they will go after many liquid tumors. They stated that they believe the total market for pacritinib is in excess of $6 Billion. If they believe this then CTI is so undervalued then their best move is to try to acquire the company as CTI's price will most certainly go up drastically if their numbers are correct. Myelofibrosis is simply the entry point to market. Expanding the label for many different liquid tumors is the key. There is no doubt that things are about to get very interesting for CTI.
8.7% is actually quite high and this level comes with regulatory filing requirements so Baxalta has already crossed into the territory of filing headaches. I want to see them acquire more. It's a great fit for them and very cheap.
If you know Baker then you know they start to ramp up their investment along with the flow of good news. I'm very happy to see them here and they certainly can bring a lot of credibility to the stock. The positive Adcom for Sprout's flibanserin should increase their confidence in Bremelanotide.
Shorts in CTIC could be playing with fire because Baxalta (Baxter) could easily buy CTIC to get rid of any potential nonsense out of the company. Sometimes it's worth every penny to get rid of a difficult partner. I'm a strong supporter of CTIC but not because of management. It's because of pacritinib which I have followed for much longer than CTIC. Pacritinib is worth much more than any other part of CTIC...there have also been some very lucky breaks for CTIC such as Gilead really struggling with Momelotinib from YM BIO. CTIC is knocking at the door of INCY. No way should we be trading below $4. And remember, Baxalta already owns 8.7% of CTIC.
There were so many vocal patients and advocates in the Adcom that the FDA is definitely facing pressure.
Sprout has also been said to have hired lobbyists to make their case. This is additional pressure.
I'm not sure how to define the type of pressure that female (not necessarily feminist) groups can put on the FDA. However, it's a fact that viagra and cialis ads play almost hourly when watching any popular television station and all of these ads are aimed at men. Female groups make the case that "female lives matter" (as one advocate stated today). We live in a day and age when even perceived bias (gender, racial, etc) can have very deep consequences. I'm of the opinion that the FDA will recognize that the time has come for female sexual dysfunction meds. Moreover, the time has come to support companies like Sprout and Palatin because this will lead to additional funding and partnerships in the sexual dysfunction space. R&D breakthroughs only occur if the FDA shows a willingness to support groups that come to the table with a reasonable registration package. Fibanserin may not be the holy grail but if it helps patients even a little bit its massive to them.
I believe that Brem offers many advantages over fibanserin but in all likelihood patients will try both.
My opinion is that a new day is upon us. Women are going to have their meds too. Both bremelanotide and flibanserin will likely have a role off label in men so this is good for all patients.
I am very confident in the approval of flibanserin.
18 to 6 is 75% in favor. That's well beyond a mixed message from the panel.
If the advisory board vote is "based more on the science and less on the politics" as you say then Flibanserin should have no trouble getting to market as the political pressure on the FDA to approve is extremely strong.
The FDA very often follows the recommendation of the advisory panel and I think you'll be in the minority if you think the FDA will go against the panel in this case.