What many investors are overlooking, IMO, is the compliance factor. Though Arikace may have not been statistically better than TIBO, in a real world setting, it will be. In a rigorous trial setting, as discussed in the CC, compliance was enforced with all patients, including those in the TIBO arm. As evidenced, TIBO works perfectly well when taken as prescribed. Unfortunately, when patients aren't being constantly monitored, some will miss doses and consequently reduce the efficacy. Each treatment takes approximately 15 minutes, twice a day. Very time consuming for young adults.
Now when a similar product is introduced that needs to be taken only once a day, prescribing this medication is definitely more desirable for physicians. As for the patients, I can't see why they wouldn't jump at the opportunity for a simpler treatment. It becomes part of the morning ritual, then done for the day.
The other event I tend to see as a major potential catalyst is the NTM fast track designation. This is huge, IMO. This means that approval may come as early as the completion of Phase II (not saying it will). Though rare and fairly recent, this designation allows new drugs to come to market faster, especially if there is no treatment to date and the disease can be life threatening. Patients and their families and pressuring the FDA to move more quickly on these candidates.
There was no doubt in my mind the analysts were going to reiterate their ratings, I saw no reason not to. So the results weren't compelling like many were hoping, the product didn't fail. Yes, many wanted to see exemplary data, and yes, many sold as a result of it barely being non-inferior, but in a real world setting, my bet goes with Airkace and it's once daily treatment. I think the physicians and the regulatory bodies will see this benefit as well.
Still shaking my head on this one. It was a terrific round table discussion on the data and CC but why the hype-building PR on Friday? I don't buy REG FD obligations either. I mean, how long were they sitting on the QIDP for NTM news?!
Building hype for 3 days was gonna be a let down unless there was indeed *Superiority* type news. Very dumb move or planned? Thanks goodness there appears to be decent COH or I would be half expecting a PIPE deal or some sort of financing coming at us right down pike after this set up.
The data does give us a legitimate company asset now which is great. But a little bit of the luster has come off Mr. Lewis, though, in my eyes. He knows the market and must have known how the results would be interpreted
Bayer spends millions and millions of dollars promoting Aleve as the "Once Per Day Pain Medication." People in pain would apparently rather just swallow one pill per day than every several hours. Swallowing a pill is far less time consuming than sitting with a mask on for several minutes of inhalation therapy. From the first day that Transave and Insmed merged and arikace was explained to shareholders, this has been the top selling point for arikace.
Another point missed big time is the fact that people are building up resistance to what they`re taking currently and the FDA knows there`s a need.Arikace is the new kid, soon be on the block and they`ll switch to get better results than they`re getting now because of their body building up resistance to the drug they`re on.The once a day compared to twice is just icing on the cake,and should make it the number one choice for sure.We`re as good as approved,just have to wait it out.