Drops like we have been seeing over the past couple of weeks are not normal. No volume, no bad news, in fact, no news at all. Something or someone is playing a game, who is selling at these prices. My guess the same one as buying. The shares are coming from one pocket into the other-- no shares are changing hands, they just want to drive the price down.
If you check the history of changes in the EU CF trial, there have been no additional restrictions in eligibility criteria.
Six year olds are still eligible. So, at least in the EU, the potential market is not smaller since the hold. We'll see how the FDA comes down.
Save, I'm sure that they have been given some guidance by the FDA within some type of a range. I don't think the FDA has told them exactly what to submit. Will Insmed go for the upper or lower end of the range? Either way, eventually I have to believe the hold will be lifted.
The CF indication, as you have said, may not be all that large. However, it is important to remember that arikace also had positive results in phase II for non CF bronciestasis. Both see the same doctors, and according to Insmeds initial investor presentation, non CF bronciestasis is a 3/4 of a billion dollar market.
I hate the current share price, but I try not to let day by day or even week by week prices screw with my mind. If arikace never moves on to approval, we have 3 dollars per share to lose at this point. As I posted yesterday before it was removed, with approval Insmed should become profitable at a far quicker pace than many bios with approved drugs. The upside remains big. JMHO.
Bo, that's why they have discussions with the FDA. If the FDA doesn't lift the hold it is because insmed didn't listen good enough to what was being said to them. Insmed should have two choices, drop the smaller indication on their own to preserve cash or follow to a tee what the fda has communicated to them about the cf design which will lead to a lift of the hold. A continued hold should result in the firing of Whitten.
<<CF is a lot smaller of a potential market than the potential market that the hold was lifted on in January.>>
Save, it is going to be smaller, but maybe it is still a little early to say "a lot" smaller.
This is tough for Insmed - Do they submit a patient population that includes only patients above twenty that have been on chronic TOBI treatment, or do they "push the envelope" and simply change the minimum age from six to ten? If they push to hard the FDA may have them resubmit what they deem a more appropriate patient population. If they don't push the envelope they may be limiting the potential market. For this reason I'm not going to be overly surprised if the FDA's initial response is no. JMHO.
I don't agree. At $8 insmed is worth $200 million. They will have to raise money, I think, so at $8 the market cap will be even more. And cf is a small indication. Because ntm was set back to phase II and significantly delayed and is the biggest potential indication but also will cost the most, $8 will probably not even happen if ntm is approved in 3 years because of all the money raising. ughhhhhhhhhhhh, so mad and sad at myself for investing in this company.
I don't think so. CF is a lot smaller of a potential market than the potential market that the hold was lifted on in January. If the hold for CF is lifted maybe we see a rise of $.5 to a dollar. Who knows if I will ever see $8 again:(