great chart read! and the hammer shown and the CMF has flowed out and the.....in reality the chart is flagging which means it is ready to break one way or the other. I've placed my bets on the direction..Above 15.80 you can read anything, but I like your style!
If P3 passes by any measure, it will be $20s by the Fall as momentum from the NTM + non-CF indications gather. If P3 shows substantial superiority, which is probable depending on the prevalence of TOBI usage prior to trial enrollment, then the secondary key measure to look at is how effectively it holds up over time.
There's really only 2 major options out there, Cayston and TOBI. Considering that approx 20% market capture corresponds to $400M in sales, as long as Arikace shows that it works (and is a different mode of action which means it gets adopted by those who grow resistant to Cayston's and TOBI's efficacy), it's going to net far more than $200M in sales needed to justify more than $15 PPS in the near-term.
Cayston crushed TOBI head-to-head, but more than 80% of the people in the trial had taken TOBI before, making it difficult for Cayston to lose. One important thing to note is that in the Cayston trial, one of the exclusion criteria was "administration of any investigational drug or device within 28 days of Visit 1 or within 6 half-lives of the investigational drug (whichever is longer)". In comparison, the Arikace excludes anyone who has taken a product within 8 weeks. So, Cayston had it easier vs TOBI with respect to Arikace.
However, Cayston's FEV1 performance goes from 8% to 2% over 3 cycles. If Arikace can show greater than 2% FEV1 after 3 cycles, then it beats the Cayston in that match-up as well. Already, Arikace's FEV1 performance in the placebo trials shows superiority to Cayston's durability, and has demonstrated an increasing efficacy trend, unlike anything seen in the other 2 options.
A 100% pop is not unthinkable if successful P3 results are released that show superiority to TOBI, and durability superiority to Cayston.
Blehair, you have obviously done some homework and are very familiar with the phase II results, as well as the Cayston results from a few years back. I think that it is important to point out that in the future, when and if arikace gains approval, cystic fibrosis patients are likely to be placed on a two drug regimen. Arikace, and then Cayston during the Arikace off period. It really isn't likely to be simply a choice of either TOBI, Cayston or Arikace. This would considerably raise the potential percentage of CF patients using Arikace, as well as Cayston. I continue to believe that upon positive results, like it or not, Gilead Science will enter the picture. The Gilead market cap has become so immense, that the company now has no reason to act before the results from the current trial are released and analyzed.