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@NoEasy
From a pharma regulatory point you could knock me over with a feather if the likes of EMA and FDA accept some attempt to make comparisons across completely unrelated studies and products as a reason not to do another study of DS to confirm it's effectiveness. From a regulatory agency's conservative viewpoint it would not even be comparing apples with oranges.
Also the 'finding' from the study reported yesterday was not part of the hypothesis and as good as that data might look, that study FAILED to meet it's primary endpoint.
In the end it is all conjecture and provides for huge uncertainty in the coming months.
The one thing that really surprises me - as MED delivery using DS had been quite widely tested before - is they had seemingly never had any signal about the potential confounding effect of DS when one considers the apparent size of effect seen in this study. That just seems hugely unlucky, but that is clinical development and why it is better to have a portfolio of products to offset the risk of failure in any single asset.
I imagine the guys at FM are having an absolutely awful few days as they will have put their hearts and souls into getting to where they've got to.
@NoEasy
It is not unusual for the vehicle (in this case DS), less the active, to be used as a placebo and presumably in earlier studies FM had not seen a signal that DS had activity on ED. In hindsight (always easy eh!) they should have used an absolutely inert placebo I guess and there was a clue in the webcast yesterday that they think DS contains so far undetermined volatile chemicals that evaporate after application and cause local increases in nitric oxide(NO) levels. The biology of this is that the NO causes local vasodilation... which increases localised blood flow... and hey presto a response is seen.
For me this is a biological effect that will need to be tested/proven against either a standard of care or a true placebo before a regulator would approve it, meaning more studies/money needed etc... and for me that is where the real problem is as it creates a hugely uncertain and risky scenario that is likely to go negative.
Also how this could be approved as a device I do not understand but I guess FM have a clear idea as to this as they were confident enough to say so clearly yesterday and presumably they will tell us ASAP?
@bandit1:
Their NOMAD will have perhaps drafted, certainly reviewed and approved the wording re the financing. The bit that is relevant and impossible to hide is the required statement that financing is going to be required. After that it is about how the company frames that news. Seems to me they have attempted to show they expect to have non-diluting routes to try to soften the post-news retail sell off that they probably anticipated as the stock is so broadly held by retail investors.
The big issue will be how their finances (or lack of) negatively impact their position in license negotiations as any licensee/buyer is going to apply pressure around that. They are going to need competitive tension to ensure that impact is minimised.
If I was them I'd try to go to the largest/most loyal shareholders and have a sensible fund raise informally agreed with them which could be ready to go post news of the trial result. It will come at a cost (might need some warrants for example) but it could significantly strengthen Futura's hand license negotiations.
A sponsor (in this case Futura) is not allowed to pay subjects to be involved in a clinical study performed under ICH-GCP guidelines, which this phase 3 study will be under as it is intended as a product registration study. If they did it, would be inducement and all data would be rejected by the regulators.
The type of mins varies massively by the division involved, the PM in charge, whether the Division director is in attendance etc...
I would expect they've got a good idea of what will be needed but are required to wait (are being told to wait by their NOMAD) until final mins are received so they don't run the risk of misleading the markets.
The level of clarity achieved on the key issues on the day of the meeting varies significantly by the division involved and the project manager (as well as other FDA attendees at the meeting). Some PMs will produce 'live' minutes reflecting the agreed (or disagreed) positions of both parties following discussion of the points at hand and these are unlikely to change much before being (quite quickly) issued to the Company; in others the FDA's PM will make notes and then provide the minutes to the company in due course (usually within the indicated timeframe, but not always). In either situation though the company is best advised to wait for the final minutes before updating the markets otherwise they run the risk of misleading current and potential shareholders which they then argue caused them to make buy/sell decisions they possibly would not have made, as well as looking really stupid. Seems there are 3 main scenarios:
1. Approve with safety warnings (not really likely as a CRL got issued)
2. Approve with significant post-marketing safety commitments (seems unlikely now)
3. Do more work and then go back to the FDA - seems likely from today's limited comments so it will depend on WHAT is required to know if it is possible and how MUCH money is required by MTFB or another party that might end up with the asset if MTFB can't raise funds. Would such a process require a new NDA and therefore a filing fee as the CRL signifies the end of the current cycle of review?
Either way it seems likely that a significant dose of medicine is coming for existings... ouch!