Daily Archives: February 20, 2017

CF Ireland says damage is being done to children with cystic fibrosis by the failure to authorise Kalydeco for those aged two to five years

New evidence has emerged to support the case for approving the groundbreaking cystic fibrosis drug Orkambi, Minister for Health Simon Harris has been told.

Newly-published data shows Orkambi, by preventing a worsening of the condition of patients, will save the health system even more than was previously estimated, according to Cystic Fibrosis Ireland.

The percentage of cystic fibrosis patients that stands to benefit from the drug is among the highest in the world, the patient group says in a letter to Mr Harris.

With the HSE due to make a final decision shortly on whether to reimburse the cost of the drug, CF Ireland has warned the Minister of a strong outcry if no agreement is reached with the manufacturer Vertex Pharmaceuticals.

Orkambi was estimated to cost 159,000 per patient per year when price talks began last year but CF Ireland says it understands there has been a considerable discount on the original list price since then.

This would indicate that the gap between what the HSE is reported to be willing to pay is not insurmountable, and with goodwill from both sides an agreement can be reached.

The group says new data published in the 2015 report of the independent CF Registry of Ireland shows the high proportion of cystic fibrosis patients in Ireland who suffer pulmonary exacerbations or deteriorations in their condition.

In 2015, 41.1 per cent of adults and 27.2 per cent of children with cystic fibrosis experienced at least one exacerbation. The average time spent by all cystic fibrosis patients on antibiotics was 35.7 days that year.

The data shows 56 per cent of Irish people with the disease has the gene alteration that is targeted by Orkambi. This compares with 50 per cent in the UK and 46 per cent in the US. Ireland continues to have the highest overall incidence of cystic fibrosis in the world.

The average lifespan of cystic fibrosis patients has increased from 13.4 years in the late 1980s to 27 years in 2014 and 30 years in 2015. The use of new and innovative drugs played a major role in this improvement, the letter says, adding: The last thing we would need now would be the denial of new and proven drugs that would retard potential and more rapid development.

CF Ireland also says damage is being done to young children with cystic fibrosis by the failure to authorise another drug, Kalydeco, for use by those aged two to five years.

Here is the original post:

CF group claims new data supports case for Orkambi approval - Irish Times

Gridshare is one of the newest Reg CF crowdfunding platforms to receive regulatory approval. While the number of Reg CF portals is growing, Gridshare is the first and only platform to target the specific vertical of renewable energy and Cleantech.

Originally launched as an accredited crowdfunding platform under Title II of the JOBS Act (Reg D 506(c)), GridShare wants to make investing in renewable energy projects accessible to a wider audience. Using Reg CF, any investor may help fund a solar or wind project typically alongside professional investors.

Founders Jack Jacobs and Jon Norling are leveraging their experience and contacts at Cleantech law partners to source promising deals and assure quality deal structure. They also intend to launch international offerings at some point in the near future.

GridShare has launched with several offerings includingEau Claire Solar, Floating Solar andGorge Windall three offering a debt investment under Reg CF.

Crowdfund Insider recently connected with Jacobs to better understand his vision for the future of GridShare and renewable energy crowdfunding. Our discussion is below.

Crowdfund Insider: Congratulations on receiving Reg CF approval. How long did the process take for you? And why did you decide to go with Reg CF?

Jack Jacobs: Thanks. Weve been refining the platform for a few years now, but the process for receiving approval from SEC and FINRA to operate as a Funding Portal was a 4-5 month process. We decided to focus on Reg CF in the United States because of the ability to reach ordinary, non-accredited investors using this exemption, which we believe offers issuers a relatively low-cost and easy method to access capital.

Crowdfund Insider:You previously launched as an accredited crowdfunding platform. Will you be doing side-by-side offers? (Reg D/Reg CF). Do you think the $1 million cap is sufficient for your issuers?

Jack Jacobs:At this point, we plan to focus on Reg CF offers in the United States and not plan to also offer Rule 506(c) or Regulation A+ Offerings.

Our affiliate, GridShare International, LLC, will be listing offerings in foreign jurisdictions that allow equity crowdfunding. With respect to the $1 million cap, we believe this is low, and support the $5 million cap proposed under the Fix Crowdfunding Act.

Because, however, most of the listings on GridSharesite will be project-specific offerings, and because issuers are typically combining the crowdfunding financing with other capital sources, such as tax equity investors or sponsor capital, we think the present cap of $1 million will allow us to continue to develop a robust deal pipeline.

Crowdfund Insider:Do you expect to see more debt offers on Gridshare?

Jack Jacobs:We absolutely do. The platform is really geared towards offerings of project-specific debt that is secured by assets. Also, because of the regulations related to tax credits and benefits for renewable energy, it is difficult to have crowd-based equity in the project companies. Therefore, secured debt financings will likely be the most common project-based offering on Gridshare. That being said, however, most issuers raising capital for venture Cleantech companies may seek to offer equity or debt that converts into equity.

Crowdfund Insider: How is deal flow? How are you sourcing issuers? And what types of Cleantech companies do you foresee listing on your platform?

Jack Jacobs:Deal flow is good! We have a ton of interest in the siteand are vetting numerous projects to determine which meet our rigorous listing standards.

Regarding sourcing, it has been a mix of organic (i.e., users posting their own projects) and us reaching our through our network to let people know about the capital raising opportunities on GridShare.

We expect to see a steady mix of project finance offerings and corporate offerings for clean technology companies.

Crowdfund Insider:Are there any tax exemptions issuers may take advantage of? What about for investors?

Jack Jacobs:While renewable energy and Cleantech companies are often eligible for tax benefits, GridShare was not designed as a site for tax-motivated investors. While our issuers structure their financings to maximize tax credits, at this point, the investors will receive monetary returns without additional tax benefits.

Crowdfund Insider: How did you decide to launch a platform for Clean Energy & CleanTech?

Jack Jacobs:We (myself and Jon Norling) are renewable energy develop and finance attorneys, and originally started the platform as a financing tool for our clients.

We started the platform soon after passage of the JOBS Act, when there was a need for lower cost of capital for renewable projects. By the time the SEC finally adopted the rules, however, lower cost capital was available to sponsors, but ordinary non-accredited investors were not able to participate in these investments. Thus, we decided to allow these ordinary investors to have access to the same type of project-finance investments available to institutional investors.

Crowdfund Insider: Any comments on how Reg CF could be improved for issuers? For investors?

Jack Jacobs:For issuers, it would be great if there was a broader array of entities able to serve as escrow agents for offerings, and if issuers could test the waters prior to committing to filing a Form C.

For investors, educating these folks is key to success of this market, and we hope the SEC and FINRA will continue their efforts to educate investors on what to look for when purchasing crowdfunded securities.

Crowdfund Insider: What are your expectations for platform growth for 2017?

Jack Jacobs:We anticipate steady growth in offerings and investments, and anticipate an increasing number of clean-technology offerings on the site. We expect that solar offerings will remain strong, but also hope to see other renewable technologies being listed as well.

Last, we think that our international division will grow significantly with the increasing interest in crowdfunding globally.

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GridShare Targets Renewable Energy Crowdfunding under Reg CF, Plans International Expansion - Crowdfund Insider

Castilla had finally gained a win in the last game against Fuenlabrada, miraculously putting them back into the playoff spots. This week, they travelled the short distance of 20 minutes from Valdebebas, to Rayo Majadahonda. Fede Valverde was back from injury along with Philipp Lienhart on the bench. Whilst Campuzano was interestingly left out of the squad, with Solari opting to rest him to avoid injury. With high-flying Campuzano away, finally Sergio Daz was finally going to get his chance back up top, right? Wrong. Solari started with a pretty standard 4-3-3, With Daz and Enzo out wide, partnering Nikos Vergos up top.

Castilla XI: Zidane, Achraf, Snchez, Hermoso, Quezada, Seoane, Febas, Muoz, Enzo(C), Vergos & Daz #RealMadridCastilla pic.twitter.com/w2S5NZco81

The game kicked off, and it was not enjoyable at all. Castilla weren't playing badly, and kept the ball well. Majadahonda did not look like punishing the defence much who were having a fine game. The problem was that nothing was really happening. There was no excitement at all. Javi Muoz was unable to run the game from midfield, Daz was predictably isolated out wide, and no one else looked like scoring a goal for Castilla. Achraf was the only bright spark in the first half, and was probably the best defensively, too! The best chance of the half fell to Daz, who missed an open goal from yards out due to a bobble. If he had any confidence in his striker-esque abilities, what must they be like now? The half dragged but luckily came to an end, and the score at the break was to nobody's shock, 0-0!

At half time it was Majadahonda making the changes, and the substitute hit the post with his first touches. Fede Valverde was brought on for his first game back, and immediately took control of the midfield. The game was still by no means fun to watch, as Tena replaced Muoz, and it seemed destined for a 0-0 draw. To try and avoid a draw, Solari brought in Cristian Cedrs for Enzo. Minutes later, a throw-in found it's was to Fede Valverde, who took a couple of touches before striking the ball goal-bound from distance. It whistled into the back of the net to put Castilla 1-0 up! A moment of brilliance to win an otherwise dull affair. The last 10 minutes were the best phase of the game, and both sides had chances. Luckily the Castilla defence held out for the win, pushing them up to third place in the league!

Man of the match went to Fede Valverde, for his short but sweet cameo, changing the game and in result handing Castilla the 3 points! It's great to see him back and Castilla have definitely missed him. Achraf also deserves a mention for a great game and Luca Zidane was strong in goal. Big game next week as Castilla host Toledo, who are desperate for a play off spot. Be sure to check it out here, and on my Twitter @CastillaStats for live coverage!

Goal: Valverde

Assist: -

MOTM: Valverde

The rest is here:

CF Rayo Majadahonda 0-1 Real Madrid Castilla - Managing Madrid