Absolutely agree. I'm quite cpnfident that potential partners were waiting for this. This shows a massive change in the stance of the FDA.
Vote was overwhelmingly in favor of approval with risk-mitigation in place. My understanding is that this is post-marketing. It's not clear if this will be more studies post marketing or perhaps prescribing timelines. So far Brem seems more effective and safer so partnering interest for PTN should now increase. The age of treatment of female sexual dysfunction has arrived and PTN should be a very important player. Congrats to all longs if you believe that Sprout's benefit translates to support for PTN.
Today someone mentioned during the FDA meeting that women purchase unproven meds over the internet and I know women buy brem off-label. This is very dangerous as one doesn't know if the drug is contaminated/pure. I have little doubt that the FDA will support brem if the drug shows well in their clinical trials. It would be good to see PTN secure a partnership sooner than later. It will bring validation to this very important program.
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.
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.
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+
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
The only point I can make is that FBIOX has a larger holding in groups like ACAD than IBB and ACAD is getting killed.
To me FBIOX looks like a good value. Groups like GILD and CELG released incredible earnings and they drive this sector. The more speculative names are selling off hard. Groups like BLUE and ACAD are fairly significant in the FBIOX portfolio and I think this is why FBIOX is getting hit harder than IBB.
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.
When you say "lift all ships" I would just say that there are very few ships to lift. A major reason for this is that sponsors are unlikely to explore this indication without some indication that the FDA will be supportive.
This also ties into PTN's ability to get a partner for Brem...if the FDA is supportive then sponsors will of course step up. BREM is just behind Flibanserin....approval of Flibanserin will be extremely important for Palatin.
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.
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.
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.
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.
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.
I agree. I worry because these payers stifle innovation. However, no one can say existing therapies are adequate so they will have to pay.
I personally like Baxalta as pacritinib is core to their strategy. I can see many ways for the CTI shareholders to win. I don't see many ways to lose with Shire at the table.
1. Baxalta isn't bought and continues to push pacritinib ahead - definitely good for CTIC shareholders.
2. Baxalta is bought and Shire becomes our partner - this is also probably good for CTIC shareholders. Either Shire advances the program (which would be similar to Baxalta advancing it or they return right to CTIC which is another big win since clinical trials are essentially done and the program is relatively close to
3. Shire becomes our partner but puts the program on the shelf. I don't see that they can do this or would want to do this. I say they would either advance it aggressively or give it back. Both are wins for CTIC.
4. Baxalta buys CTIC. To me this makes sense for so many reasons. First, CTIC is cheap and Baxalta has to recognize this if they believe they own revenue projections for pacritinib. Also, one would think the mgmt of Baxalta is made up of business people who would take out a partner if that partner was important and the program was cheap. Finally, Baxalta needs to make clear why moving forward with Shire doesn't make sense. One way to do this is to start buying things as well.
I don't see any obvious clouds on the horizon for CTIC and I do see a potential buyout. All my opinion of course.
Yes, close enough to have a similar day but there are some key differences. I like the exposure that FBIOX has to some of the smaller emerging companies. Both have it but FBIOX is heavier in some of the names I like.
I took this opportunity to enter today. Biotech isn't in a bubble when groups like Gilead post such strong earnings. Also, some companies will drop 90% but you're unlikely to find those companies highly represented in the FBIOX portfolio.
Hi Sanjeev, I meant to respond to your post sooner. I agree that Bianco could be manipulating the price to make for a sweetheart deal with Baxalta. His comp plan pays him very well in an M&A deal..even a bad one! However, now he has some real pressure (if he was doing this) because Shire is knocking on the door of Baxalta. If that discussion gains momentum it would back-burner any potential deal with CTI. If I'm Bianco I'm trying to sell CTI to Baxalta right now. Maybe I'm even willing to take $3.50-$4.00 to get a deal done because Bianco knows that Shire may or may not be a supportive partner should they end up buying Baxalta. I think Shire would be supportive of the program, but you can never tell with these groups that aggressively grow via M&A.
If Bianco is keeping the price low then it's low enough now that a $3.50 deal could probably buy the whole company. Not many shareholders would fight for more. No one likes this management team or believes they know how to get the price up.
For Baxalta it's a win-win-win. They gets all rights to pacritinib, they do away with CTI's management team so decision making is easier and they can use the full ownership of CTI's assets as a bargaining tool in future negotiations with groups like Shire (or others). They need to argue that Baxalta is worth more than the value that Shire proposed and one way would be to fully own pacritinib and CTI's assets.
There is an x-factor here....Bianco owns a decent amount of shares but an activist investor could move in here if they wanted to. His comp plan again protects him, but these things can always be challenged legally. This is especially the case if it can be shown that he breached fiduciary responsibilities. The bottom line is that CTI should be trading much higher. If there is a conspiracy here then I expect Bianco to get a deal done very soon.
We obviously all make more money if a deal doesn't happen right now and the story actually matures.