Well, yeah right. I think I mentioned Dr. Mulder (general partner, Forbion) some time ago. Just look at the list of companies in his managed portfolio. And now this August 5 thing…whatever that means. With Forbion, a new marketing company doing a global campaign, Lewis and UniQure (Aug 5)…
A lot of smoke...
I just thought it odd that as he newly joined the uniQure BOD, he was then immediately appointed Supervisor Director of the STAK after the STAK board was dismissed. UniQure just IPOs, raises scads of money, converts the DRs and issues shares for what can be viewed as nothing other than staging for tremendous growth...and Lewis gets pulled in. What is it about August 4 (when the DRs end) and August 5 (when the new common occurs, or thereabouts)? This is not the only echo of August 5 I have heard with Lewis in the middle.
So, you know about August 4/5 and the STAK DR conversion, cancer liposomals, all the magnificent growth into a multi-billion dollar company within the next 12 months, and....
Might as well think big!
Oh...June 27 the EMA did a change of address for Insmed.
Interesting that the favored tax change strategy mentioned for Insmed's increased valuation and target price would parallel AbbVie’s move to Ireland to reap tax inversion benefits.
In London yesterday, the EMA held a fast track symposium. They are trying to model the FDA changes to speed up bringing critical unmet needs to market. The symposium was for companies to learn how the EMA would help, how to leverage their assistance, and work through the process. I half expected someone to post an inquiry about Insmed attending, if they did. You know...the normal blather. As I recall too, they are also having some liposomal applications discussions. Heck, I even think HHS has even extended a grant for liposomal evaluations...trying to identify meaningful metrics. I'll have to check if that has been awarded yet.
I was waiting to see where this would go and thought too that it was iPlex related.
iPlex is approved in the U.S, but the FDA would require equivalency of a new production facility if maintaining the same trialed formulation. If the formulation, folding technique were changed then it would be conceivable that new trials, albeit different, of the new iPlex formulation would be required. Even then, the trials would be aimed at equivalency and not effectiveness, etc. It would all depend though on variation form of a new iPlex. Let’s assume the production facilities and previously existing strains remain intact. The return to market could be as simple and as short as resumption, inspection, and certification of the production. But that is not likely.
I know I once said after the settlement how I would play it (find a new product and wait for a 2018 return), but now I think the best strategy would be to license iPlex and pursue other indications of liposomal medicament delivery. The settlement prohibited Insmed from enabling anyone from developing an IGF/IGFBP-3 compound. Besides, with Shire (acquired Premacure) now moving into phase 2 on ROP, one might reasonably expect their interest in other applications. I just think Insmed found themselves a cheaper more versatile solution to market after the iPlex settlement…I really like where we are today.
Actually, it probably has a positive benefit on the share price short term. If any interest from new investors could be tempered by his incessant nonsense, there is less inflation in the run-up making it more sustainable or at least cushioning the eventual short term profit taking. So, we should thank him.
In all likelihood, yes. The planned trial will become a PIV. There should not have been much doubt. The FDA wanted conversion data to begin with.
WKSI is curious in that it allows for multiple classes of securities, but where is the $700M market cap or $1B offerings in the last 3 years.
As for any potential partnerships, could not such necessitate additional shares?
That's curious...I posted a tongue-in-cheek about a looming new stock issue and the ensuing dilution, but that post is gone.
Any who...the availability of shares does not satisfy the institutional interest. Regrettably the millions raised will have to go towards commercialization.
The COMP minutes often provide better insight of a decision than the formal public opinion which guides any press release. It takes 60-90 days for the public opinion and the meeting notes to be published on the EMA web site; so the February press release did not clue us on anything other than Arikayce received a position orphan opinion (this was PR’d) and then in April the formal designation was granted (not PR’d). And now in May, we see the meat and potatoes behind this EMA decision.
The EU has approved the use of intravenous amikacin for NTM. During the COMP discussion February (this is when they issued the positive opinion for Orphan) they said LAI is sufficiently justified (by data) to provide a significant benefit for patients. They have signaled a likelihood for approval if the trial data supports improvement of side effects over intravenous and effectiveness (both of which now supported by data).
Minutes from the February COMP meeting:
“although satisfactory methods of treatment of the condition have been authorised in the European Union, the sponsor has provided sufficient justification for the assumption that the medicinal product containing amikacin sulfate may be of significant benefit to those affected by the condition. The sponsor presented early clinical data showing better lung penetration and lower incidence of side effects as compared to the existing intravenous formulation. The Committee considered that this can translate into a clinically relevant advantage for patients affected by nontuberculous mycobacterial lung disease, as there are well-known and documented side-effects of the existing intravenous Committee for Orphan Medicinal Products (COMP) Minutes of the 4 - 6 February 2014 meeting EMA/COMP/77369/2014 Page 14/31
formulation that limit its use. In addition, the possibility of using amikacin by inhalation has the potential to result in a major contribution to patient care by allowing the outpatient administration of the product.
A positive opinion for amikacin sulfate, for treatment of nontuberculous mycobacterial lung disease, was adopted by consensus”
Public opinion of EMA orphan for NTM on 5/8 published.
Also, a Change of Address was filed with the EMA 8 days ago.
This reminds me...I meant to point out the durability. The data on the poster suggests that over 90% of those who go culture negative remain culture negative through 168 days.
in - adverb
"at, within, or to a short distance or time"
so "In the next several months..." may mean "Within the next several months..."
and that is not a spin, but just an example of the complexities of the English language and how meaning can become distorted and cause confusion.
…There were no unexpected adverse events (AEs), and treatment-emergent AEs were consistent with underlying CF disease. Minimally important differences…on the Respiratory Symptoms scale were observed at the end of all treatment cycles with LAI, but only after the first cycle with TIS. Improvements…on- verses off-treatment were observed with LAI on the Respiratory Symptoms (P LT 0.01), Physical Functioning (P EQ 0.01), Vitality (P EQ 0.03), and Health scales (P LT 0.01). Improvements were observed with TIS only on the Physical Functioning (P EQ 0.02) and Vitality scales (P EQ 0.02). Treatment Burden with TIS was greater on- verse off-treatment (P LT 0.01); there was no difference on- verses off-treatment with LAI. Differences in the on- verses off-treatment effect were significantly greater for LAI on the Respiratory Symptoms (P EQ 0.03), Treatment Burden (P LT 0.01), and Health scales (P EQ 0.05).
Really strange. Not all of my post "posted" and I have tried 3 times to provide the reference, but those disappear. My original post included the P-values which showed statistical significance on multiple endpoints.