So our current share price assumes the only use of Arikace in two years time will be in the treatment of about 10,000 of the 450,000-odd cases of MDR-TB?
"The inclusion of the three-month course of Arikace which converted 25% of the Arikace arm in the NTM study to culture-negative would cost around half as much as bedaquiline."
OK - we know -
1. from that CDC guidance about off-label use of bedaquiline that most drugs used to treat TB are off-label.
2. that amikacin injection is routinely used to treat both drug-resistant NTM and drug-resistant TB.
3. that two companies (undisclosed) approached Insmed some time ago with a view to a deal to commercialise Arikace in Asia.
4. that the Chinese regulatory authority is expediting its approval process for bedaquiline.
5. that the $30,000 price of a 24-week course of bedaquiline (assuming the Chinese health authority pays that much) is around twice the anticipated price of a 12-week course of Arikace.
6. that a 12-week course of Arikace converted 11 out of 44 patients with drug-resistant NTM to culture-negative within 12 weeks - the majority within 4 weeks.
7. that China is currently seeing around 120,000 new cases of MDR-TB each year on the mainland alone.
What we don't know is the extent to which China will be motivated by the risk of loss of hearing and kidney damage which comes with a six-month course of aminoglycoside injections to pay the difference in price between amikacin injection and Arikace.
Everybody else - how likely is it realistically that there's been a development in our investment with such catastrophic implications that it will stop Arikace going on sale in Europe next year (and being used off-label all over the World almost immediately in place of amikacin injections) -
and furthermore - that the secret sell-off we're seeing as a result of this setback happens to have coincided perfectly with the general biotech sell-off?
"What did the NIAID expect the FDA to do if the study had delivered the results everybody was expecting - evidence that Arikace reduced the bacterial load of an NTM patient?"
Good question. At face value all the NIAID could reasonably have expected is to be asked to conduct another NTM study.
Nobody's disputing your point. But I don't see GILD or BIIB on that list.
We're asked to believe that "other" investors have been selling like crazy all of the biotechs in their portfolios which aren't yet earning revenue - because "other" investors are too stupid to appreciate the difference between all of the biotechs out there which aren't earning revenue and a biotech which is all but guaranteed to have a substantial revenue stream within twelve months or so - and is therefore virtually guaranteed to be worth at least five times the price for which these "other"investors are selling their shares today.
I personally believe that these "other" investors are an urban legend.
Not for me. From one extremely silly price to another extremely silly price - what's the big deal?
But if it turns out these shysters are doing this with a private guarantee that the BOD will reward them with an offering priced at wherever they manage to drop the share price to - perhaps we should consider ways of making our feelings felt at the AGM.
I suspect the BOD will have too much tute backing for the small retail vote alone to result in anything more than a token protest. And maybe I'm wrong in thinking they'd stitch us up again.
But let's be quite clear on who is to blame for the pain we've suffered in the last few weeks. If the BOD had taken a firmer line with the last two offerings this would not have been possible.
The problem is that there's nothing anchoring the share price.
Investors outraged by the recent drop in the share price are wet behind the ears. The time to be outraged was last July - when we received proof that the Insmed Board had stabbed us in the back by choosing to line the pockets of their tute buddies at our expense.
Another leadership team might have made it clear to the market that they would only issue shares at a price which reflected reasonable revenue projections based upon the virtual guarantee of European commercialisation provided by the Phase III success.
In choosing not to do so they left the share price unanchored - allowing the manipulators to take it wherever they can make the most profit along the way.
A share price of $10 at this juncture is only slightly more outrageous than a share price of $30.
I'm guessing there are so few shares available from retail holders now that the manipulators have taken the view that if they are going to see the same number of forced sales at $10 as they are at $20 - they may as well take the price down to $10 and buy them at half price.
They are doubtless also triggering some locking-in of profits by investors who bought on the day of the results in the range between $12 and where the price settled.
Negotiations on a deal in Asia will have started in earnest now that Insmed has hard proof of efficacy - but these things take time.
For me our best hope is confirmation by the FDA of Breakthrough designation.
But we still need something to anchor the share price - and I've no confidence that the BOD hasn't once again issued a blank cheque to the manipulators.
I'm just about to check. Did you manage to open the attachment I included yesterday? I sent you a follow-up today.
And before I do check your e-mail - if you included an apartment number I'm willing to bet it's a two-digit number, involving only one digit :-)
A few obervations by speakers at the FDA-sponsored Non-CF Bronchiectasis workshop in 2012 - which explain why the FDA approved bedaquiline as a therapy for a drug-resistant mycobacterial infection on the basis of Phase II culture-conversion -
1. [ Our next speaker is Joe Toerner, Associate Director for Medical Affairs in the Office of Antimicrobial Products at CDER.
He, in his responsibilities, deals a lot with guidance development for various infectious diseases, and so is in a good position to give us a regulatory perspective on clinical trial endpoint measures. ]
[ And for pulmonary tuberculosis, we consider sputum culture conversion to no growth, which is a biomarker, but we consider that a surrogate endpoint that could be used for the purposes of accelerated approval. ]
2. Speaker: Anne O'Donnell, MD
Primary Endpoint in Clinical Trials
[ I still think, with NTM infections, that we've got to use sputum culture as the primary endpoint.
I think we could probably discuss that a little bit more, but I think for right now that is the one type of bronchiectasis that we still need to stick with the sputum culture conversion. ]
Anne O'Donnell later in her talk referred to the case history of one of her patients (below) - a tale which will have done no harm at all to the chances of the FDA approving Arikace :-)
If there's no logical reason to believe the NIAID and FDA are particularly interested in a new NTM therapy - by a process of elimination they can only be interested in a new amikacin therapy.
[ But when she came back from the Mayo Clinic she was followed by her community physicians, actually here in Silver Spring.
And they never really got it that she had pseudomonas, and ultimately she got in the hands of somebody who had her on a prolonged IV course of amikacin.
And it knocked off her kidneys, so she had aminoglycoside renal toxicity, developed renal failure.
She ultimately came to us and she's doing well now. She's had a renal transplant. ]
Problem is he has a track record going back to the 90s of making up stories aimed at imparting credibility to the delusional drivel he posts.
Apart from claiming under a couple of ids that he has dyslexia, he also posted both of the following -
"As a Mexican and a mother with students at SD State,I saw arguments like yours with the schools football Logo,and simply laughed.
When I lived in the D.C. area some fools were
complaining about the Redskins name as being (roll call please-politically correct word! _ Culturally Insensitive !!!
I think whiners like marty need to - GET REAL"
"did you get to look into what a real doctor might say ?
I did.(Yes I am Latino, and Ill bet this where a BIG market is ! huh !) lots of Off label - maybe hundreds of millions"
I've seen lots of posts which include suggestions that there is diabetes in the family - but is that any great surprise for a loser who wants it to be thought his opinions are of value concerning a stock which is heavily reliant upon developing diabetes therapies?
Look back at the famous "cocktail party" post. If there was a diabetes connection one wonders why he never mentioned it then.
Either he made up the story about the diabetes or he made up the story about the cocktail party. My money says both were lies.
Btw - I couldn't make sense of the info you posted about his profile mentioning Wounded.
Would you mind either having another go or e-mailing it to me please?
You need the help of a "friend" with a different id. The block prevents you from replying to your own post.
But many thanks for helping to nullify the silly games of the DHW.
It would only take a couple of more like you and the DHW wouldn't bother. Above all he hates being made to look stupid.
"in the anti-infective space generally, what we're seeing is a real engagement on the part of regulatory authorities where there is efficacy and safety to find a pathway forward to get these drugs onto the market - whether it's through breakthrough therapy, QIDP designation or indeed, just evaluation of final data outcomes"
Would a regulatory authority go so far as to grant QIDP status for a drug in a clinical trial for a non-contagious disease so that the regulatory authority could then use the data from that study, along with data from other studies, to support fast-track approval of the drug to treat not only that non-contageous disease - but other diseases which DO have the potential to pose a serious threat to public health?