Historian, Read through the mission statement and the comments from the employees that work there on the career opening page. They talk about thinking outside the box, pushing the limit, collaboration, and cross training as part of the work environment at Insmed. I don't know if that translates into a dual purpose for a couple of different drugs, but I wouldn't be shocked that there are employees that could work on both Arikayce and Iplex if the opportunity develops. Insmed's challenge is to work on rare orphan like diseases where a difference can be made to the lives of the afflicted. With about two years to go on the court settlement, Insmed will sell the opportunity to someone else, or decide if the opportunity is theirs to keep. If they are going to keep it, they will have to do their own due diligence with their new employees to determine if it's an opportunity they want. A lot has changed since 2009 when they agreed to the settlement.
If you were a business and were getting ready to sell a product or service in a new market on September 1, I doubt you would fly by the seat of your pants to begin marketing the new product or service on August 31. You would determine the cost of making the product, advertising and marketing, getting a sales force or customer service team together and making sure they were knowledgeable of the product and/or service. In addition, you would have to know how to distribute that product in an efficient manner, or how you were going to efficiently produce that service with knowledgeable employees. You might need a lead in time of 6 to 12 months to properly plan the rollout. (This is all similar to the possible European rollout if Arikayce is approved)
The same goes for Iplex. whether or not it's Insmed, a partnership with Insmed, a licensing agreement with Insmed, or an outright sale to another drug company, a lead time would be needed to jump thru any regulatory, manufacturing, marketing, and distribution of the product. My guess is that Insmed does not wait til mid 2018 to do something, as there are patents that have a limited life of protection, and Insmed will possibly have something to say about it in 2017. Iplex has already been approved. A court settlement put everything on hold. Some entity will want that drug!! Hopefully, we will see how good a businessman that Will Lewis is. My bet is that Will Lewis has had discussions with entities that have interest, and that a select few know the value of those discussions, and what it could be worth to the company. If he has not had those discussions, I would consider him not a good CEO, but his financial background and previous drug company exposure taught him due diligence. So we will see!!
Arikaycerocks. If a doctor's job is to find relief, help cure, or assist a patient maintain a healthier lifestyle, there would not be a reason to use whatever drugs that were available, even a drug that was off label. If the cost was reasonable and it didn't harm the patient, and it brought relief to symptoms, it would be common sense to include that drug to help the patient improve. Off label is off label. A drug company probably has a good idea at the time of approval what off label areas might be a consideration for their drug. I see no reason for a drug company to publicly state the off label uses as they await a decision for approval.
It's been a good return for the traders the last few days. about 11% drop. This seesaw should go on for about another month or so. You are right, might be time to start buying some more.
Recent 10-k reports that oral presentations to CHMP committee would be in 2nd quarter, and they would expect an EMA decision by middle of Year (June/July)
I know of some drug companies that have built small drug making facilities for research purposes, and making small patches of potential drugs for clinical trials and or test runs to determine the time and cost to make small bathches prior to the larger batches being produced. It's possible a facility could be out there that may have been able to make those batches (premiplex)!
For some reason, I thought some of the clinical trials for Arikayce followed some protocols that were used in other clinical trials for possible TB drugs. Would you know if that is true? If the Arikayce clinical trials used some of the same benchmarks, and if Arikayce was successful, it would make some sense that TB could be a target indication to go after.
Jad, I don't why the delay exactly, but maybe it has to do with what Lewis describes to this analysts question.
and they want to explain it further.? He said it was compelling!!!
Q. It seems like the responses to the 100-day questions are taking a bit longer than we sort of expected. Are there any surprises in those questions around the NTM opportunity? Is there any more color you can give as to why this is taking a bit longer than we're used to.
Will Lewis, Insmed
Yes. No, and that is by design. So, I appreciate the question.
To refresh everyone's recollection, the 112 study which forms the basis for the evaluation of our application, had a one-year patient follow-up, which finished up in sort of the third quarter of this year, give or take.
And the CSR that is written for the -- at the tail end of the completion of the study, had to be done. Now that we have that one-year data, and it so compelling, it's really critical that we get that final data included in the CSR.
So, we originally went back to the EMA, we requested the six months to be able to submit by the end of the calendar year, so that we could include that CSR from the 112 study. That's a really important point. It is -- everything else is ready to go. That particular CSR has got to be in the dataset
Okay. On the EMA, you asked, NTM-only, and the strategy there, and why step away from CF.
The similarity challenge is what provoked our belief that it would be wiser to return to CF at some point in the future. Again, we hit our primary end point on the Phase III study across Europe in CF.
By setting aside that opportunity for now, it enables us to focus our resources on NTM. Obviously, there's a lot going on at the Company, but I think this is also the right strategic move.
When we look at where we end up, if we can secure NTM approval in Europe, this is an appropriately unmet medical need that this drug, we think, is going to make a material difference in. Some of the best examples of the regulatory posture with regard to that, at least, on a country basis, can be seen in France where the ATU approval, which is getting reimbursed at around $60,000 US a year, shows that there is both a recognition of the need, and a support for the use of this drug.
And I think that is probably the best harbinger of what the commercial opportunity, we think, is for ARIKAYCE in the treatment of NTM, if it's approved, across Europe.
Does that answer your question? I think CF is off the table for now. There is the opportunity to return to it, but I think in a world that is genericizing, inhaled CF antibiotics, is not the area of greatest unmet medical need, and that's what's driving our decision.
Arikaycerocks. Since Insmed did receive funds from the CF Foundation, I suspect they have to demonstrate that the research money went for something viable. By dropping the CF indication in their NTM application, it appears on the surface that Insmed did not want to tie up money, research, and time, the most valuable of the three in order to move the application along. However, pulmonary problems for those with CF and NTM seem to have some commonality in being able to treat those indications, as there are in some instances where several drugs are able to work on both CF and NTM.
Since NTM is a disorder with unmet medical needs, it just seemed logical that if Insmed receives approval for Arikayce for NTM, it might be able to use the product in other pulmonary problems that include CF or even TB in some circumstances. Might point was that Insmed would not announce any intention of that occurring, but that pulmonary physicians would know what other indications that Arikayce could be used to treat those who need more than what's on the market today.
Arikaycerocks. Interesting information you've presented. Makes you wonder if Will Lewis and the BOD is aware of this information based upon all the research done by them, and all of the physicians who have worked in preparing the clinical trials. The medical conditions you mentioned are very serious problems for many more individuals than those who have NTM or CF. The common denominator in treating those infections in the future seems to be the pulmonary pathway of getting the medicine to a location that has the least amount of resistance and problems, but has the best potential to treat the problem.
I would think the EMA & FDA both have knowledge that Insmed might be one of select number of companies that might offer a solution that better serves the patient than the injections or oral deliveries. This nebulizer delivery has to be the next best future delivery option to treat these conditions, and I think Insmed knows this too.
However, I don't think Insmed will discuss this until they receive some form of marketing approval. If the FDA is calling for help with the resistance to antibiotic problems in today's world, they certainly should be aware of the options. Hopefully, the FDA's rules & regs won't delay the FDA in fast tracking something like this to the consumer.
Sure you are. Why would you give a hoot about Terry, always rushing to defend him. Nobody else would. Nice try Terry. You are the only one that can delete your own posts, or another person can delete their own posts that you respond to, or Yahoo can if they the post is not appropriate. Keep Lying Pinochio!!!
Well, its obvious that Terry doesn't like what Arikaycerocks and others place on the board, so he tries to hide it. What a Loser for a grown up "Engineer"!