For those who haven't yet done so I urge you to take the time to listen to the recent presentation by Lewis.
Both of the presentations over the last few days are worth considering. The earlier one by Matt Paul(?) Head of Commercial is interesting in that it offers a different perspective. But if I point out that this latest from Lewis is accompanied by four slides rather than the usual 26(?) it should alert you to the fact that this presentation is very different to the standard Corporate Presentation.
The format is basically an extended Q&A - the questions primarily being fired at Lewis by the Canaccord analyst Rita Baru(?). (Apologies for so many question marks - I can't be bothered to go back to verify the details).
It seems to me that Lewis is now starting to fill the gap between what Insmed has traditionally been saying and my fantastic speculation. Listen out for clues that both the FDA and the European regulatory agencies are likely to welcome Arikace as an answer to their prayers for solutions to the threat posed by antimicrobial resistance. Lewis actually mentions the "catastrophic threat" comment from the UK Health supremo I've quoted once or twice.
Understand the big picture and you should understand my prediction that neither the FDA nor the European regulatory agencies are likely to issue a label for Arikace which DOESN'T include every situation where amikacin injection is routinely used to treat a pulmonary infection - including MDR-TB.
Lewis earlier this year (re NTM) -
"IV amikacin is used to treat this patient population right now. You can't get enough amikacin into the lung through IV to successfully address this disease."
The antimicrobial resistance issue also predicts FDA approval of Arikace for CF on the strength of the data from the EMEA study. Poor patient compliance with regimens which require two or three sessions of inhaled antibiotic each day has been a major factor in the evolution of pathogens with resistance to Tobramycin.
Lewis - "So - we'll be able to reach out to them any time we want. I don't anticipate it being that regular a dialogue other than to say, you know, as we have questions or we have ideas that we want to share with them and potentially resolve or get guidance on we can do that at our discretion.
And they're very willing to engage in that dialogue. I mean the whole purpose of the Gain Act, the overshadowing of this effort, is to find ways to expedite the approval of drugs that are novel in the treatment of underlying infectious disease where there is such a problem with resistance development." ***
Analyst - "If you can get approval on the data coming up is it going to be conditional approval? Would you need to do a confirmatory trial? If it's not enough for whatever reason, what would a Phase III trial possibly look like?"
Lewis - "So I think we always want to plan for the need for additional data. And it certainly is worth remembering that in the interests of identifying the best clinical use of the drug additional work is always a prudent thing to plan for.
Having said that - I believe this study will stand on its own, and will be adequate for registration and approval".
"I think anything that shows promise by way of reduction in bacterial density will be enough".
Analyst - "Strategy in Europe ... do you have something in mind, or are you really waiting for NTM on this?"
Lewis - "No, we're charging full steam ahead. Again, I want to emphasise the data we got in phase III - we met the primary endpoint. We're going to be the first treatment for CF that's once a day. Compliance is a major issue in this space." ***
"You might throw in Arikace frankly more frequently because patients are more likely to take it. And if you're getting to the MIC with once-daily dosing then you might rotate in the other antibiotics less frequently."
"You know this is really a pretty disruptive introduction into the CF treatment market, to have a once a day portable therapy."
CEO Lewis - "Having said that - I believe this study will stand on its own, and will be adequate for registration and approval."
NPD Terry - "Management imho has been telegraphing what the offering was for.. additional data for NTM ? of a Phase3 trial for both NTM and CF ..."
Btw - although there's a compelling argument for the FDA to approve Arikace for Cystic Fibrosis, is it a safe assumption that Insmed wants that to happen?
The Company been saying for some time that Arikace would be priced significantly higher as an NTM therapy. If it was available as a CF therapy at a cheaper price, would there be anything to stop physicians simply buying the cheaper therapy irrespective of intended use?
I'm pretty sure that somebody with CF who needs maintenance therapy for pseudomonas can also be argued to need maintenance therapy for NTM. Would approval for NTM also be a back-door approval for CF - and allow the Company to sell Arikace in the US only at the higher price?
But, you did bother to listen to this cc, while you poo-poo'd the quarterly call. And in this current message you are remarkably complimentary to WL.
How many people post under the fud alias. Did the psycho fud get replaced by this fud 5.0?
You are definitely a lying sos.
Just remind me if you will - how many times now have you branded me a liar without ever having offered the merest scrap of evidence?
Is this your idea of conducting yourself like a mature adult who doesn't have a psychological disorder?
No comment satltsasw?
Then here's the question which will make you look as pathetic as every other poster who has resorted to accusing me of being dishonest - why don't you quote something I've posted which is clearly an intent to deceive?
OK - let's get the easy one out of the way first. What precisely did I post which suggested I "poo-poo'd the quarterly call"?
I didn't listen to it live, but I don't recall feeling any obligation to explain why that was.