. According to Rick Wise of Leerink Swann, who said he spoke to a regulatory consultant, how quickly this issue is resolved will depend on Boston Scientific's stance with the FDA and how proactive it is in tackling issues. The consultant told Swann that the best case scenario is a resolution could come in days. Other options include a 30 day notice process or a 180 day supplement review process. . . 
Share:  .<span class="sent"> According to <span class="analyst">Rick Wise</span> of Leerink Swann, who said he spoke to a regulatory consultant, how quickly this issue is resolved will depend on <span class="company">Boston Scientific</span>'s stance with the FDA and how proactive it is in tackling issues.</span> The consultant told Swann that the best case scenario is a resolution could come in days. Other options include a 30 day notice process or a 180 day supplement review process. . . Tweet this 

Analysts were happy that Athena resolved the accounting issue quickly, but were, however, less enthused about the extreme conservative nature of the 12 year amortization, with one health care analyst describing it as "draconian." "It was pleasing to see that the issue was resolved quickly, but the revenue outlook is a bit puzzling as a result of the fact that Athenahealth opted to recognize revenues over 12 years," said Leo Carpis, analyst at Caris & Company. George Hill, a health care analyst with Leerink Swann concurred, saying, "I do find it overly conservative. When the news first broke I started looking at other companies with similar issues and no company has gone as far out as a 12 year amortization period.". 
Share:  Analysts were happy that Athena resolved the accounting issue quickly, but were, however, less enthused about the extreme conservative nature of the 12 year amortization, with one health care analyst describing it as "draconian."<span class="sent"> "It was pleasing to see that the issue was resolved quickly, but the revenue outlook is a bit puzzling as a result of the fact that <span class="company">Athenahealth</span> opted to recognize revenues over 12 years," said Leo Carpis, analyst at Caris & Company. <span class="analyst">George Hill</span>, a health care analyst with Leerink Swann concurred, saying, "I do find it overly conservative.</span> When the news first broke I started looking at other companies with similar issues and no company has gone as far out as a 12 year amortization period.". Tweet this 

"I think they are looking for more specificity," Pfeffer added. "We won't know until we meet with [the FDA] and ask them what they mean by that.". Leerink Swann analyst Joshua Schimmer said it was his impression that MannKind was "still working to get a handle on how to address the issues raised by the FDA.". He said there were a "substantial number" of key unknowns raised by the FDA's letter, which Schimmer said "leave us somewhat uncomfortable," given MannKind's "inability" to rule out a potential requirement for more clinical data on further FDA consideration, the need for a future advisory panel review and the potential that the labeling might restrict use of Afrezza to patients not suitable for insulin. 
Share:  "I think they are looking for more specificity," Pfeffer added.<span class="sent"> "We won't know until we meet with [the FDA] and ask them what they mean by that.". Leerink Swann analyst <span class="analyst">Joshua Schimmer</span> said it was his impression that <span class="company">MannKind</span> was "still working to get a handle on how to address the issues raised by the FDA.".</span> He said there were a "substantial number" of key unknowns raised by the FDA's letter, which Schimmer said "leave us somewhat uncomfortable," given <span class="company">MannKind</span>'s "inability" to rule out a potential requirement for more clinical data on further FDA consideration, the need for a future advisory panel review and the potential that the labeling might restrict use of Afrezza to patients not suitable for insulin. Tweet this 

"At this point, there is just uncertainty as to what the FDA is looking for," said Joshua Schimmer, a New York based biotechnology analyst at Leerink Swann & Co. Schimmer, who rates MannKind an "underperform," said there may be a need for more trials or the product labeling may be affected. MannKind's request for an end of review discussion raises concerns that the FDA request will complicate the company's plans, he said. 
Share:  <span class="sent">"At this point, there is just uncertainty as to what the FDA is looking for," said <span class="analyst">Joshua Schimmer</span>, a New York based biotechnology analyst at Leerink Swann & Co. Schimmer, who rates <span class="company">MannKind</span> an "underperform," said there may be a need for more trials or the product labeling may be affected.</span> <span class="company">MannKind</span>'s request for an end of review discussion raises concerns that the FDA request will complicate the company's plans, he said. Tweet this 

On top of the Sutent flop, the company also announced that it's discontinuing a phase 3 study of its non small cell lung cancer drug figitumumab because an outside safety committee said it was unlikely to have any effect in patients. "We view these announcements as disappointing but not surprising given the events that occurred last year surrounding these cancer compounds," wrote Leerink Swann analyst Seamus Fernandez in a note to investors. "However, we acknowledge that these R&D failures continue to drive negative investor sentiment even though they do not affect our revenue forecasts." . 
Share:  On top of the Sutent flop, the company also announced that it's discontinuing a phase 3 study of its non small cell lung cancer drug figitumumab because an outside safety committee said it was unlikely to have any effect in patients. <span class="sent">"We view these announcements as disappointing but not surprising given the events that occurred last year surrounding these cancer compounds," wrote Leerink Swann analyst <span class="analyst">Seamus Fernandez</span> in a note to investors. </span>"However, we acknowledge that these R&D failures continue to drive negative investor sentiment even though they do not affect our revenue forecasts." . Tweet this 

Allergan's Lap Band devices account for about 70 percent of the market, according to Gary Nachman , an analyst at Leerink Swann in New York. 
Share:  <span class="sent"><span class="company">Allergan</span>'s Lap Band devices account for about 70 percent of the market, according to <span class="analyst">Gary Nachman</span> , an analyst at Leerink Swann in New York.</span> Tweet this 

If approved, the drug will be sold in the U. S as Esbriet. It is already approved and sold in Japan as Pirespa by Shionogi and Co. Leerink Swann Research analyst Howard Liang said the panel committee members' questions to the company don't seem "especially" critical so far. In a note to investors, he said the company addressed the issue of potentially damaging liver side effects by showing patients returned to normal liver function when doses of the drug were reduced or discontinued. "The company noted clean safety experience since the drug's approval in Japan and proposed liver function monitoring in the label," he said. Liang reaffirmed a "Outperform" rating for the stock. 
Share:  If approved, the drug will be sold in the U. S as Esbriet.<span class="sent"> It is already approved and sold in Japan as Pirespa by <span class="company">Shionogi</span> and Co. Leerink Swann Research analyst <span class="analyst">Howard Liang</span> said the panel committee members' questions to the company don't seem "especially" critical so far.</span> In a note to investors, he said the company addressed the issue of potentially damaging liver side effects by showing patients returned to normal liver function when doses of the drug were reduced or discontinued. "The company noted clean safety experience since the drug's approval in Japan and proposed liver function monitoring in the label," he said. Liang reaffirmed a "Outperform" rating for the stock. Tweet this 

The last five similar biotechs acquired for cancer drugs commanded average prices 9.5 times greater than annual revenue, Leerink Swann & Co analyst Howard Liang said in a telephone interview. Astellas would need to offer $59 a share to match that premium, Liang said. 
Share:  <span class="sent">The last five similar biotechs acquired for cancer drugs commanded average prices 9.5 times greater than annual revenue, Leerink Swann & Co analyst <span class="analyst">Howard Liang</span> said in a telephone interview.</span> <span class="company">Astellas</span> would need to offer $59 a share to match that premium, Liang said. Tweet this 

Melville, New York based OSI has increased 62 percent in the last 12 months, including a 52 percent surge since the Astellas bid was made March 1.9.5 Times Greater. The last five similar biotechs acquired for cancer drugs commanded average prices 9.5 times greater than annual revenue, Leerink Swann & Co analyst Howard Liang said in a March 4 telephone interview. 
Share:  Melville, New York based OSI has increased 62 percent in the last 12 months, including a 52 percent surge since the <span class="company">Astellas</span> bid was made March 1.9.5 Times Greater.<span class="sent"> The last five similar biotechs acquired for cancer drugs commanded average prices 9.5 times greater than annual revenue, Leerink Swann & Co analyst <span class="analyst">Howard Liang</span> said in a March 4 telephone interview.</span>...<span class="sent">The last five similar biotechs acquired for cancer drugs commanded average prices 9.5 times greater than annual revenue, Leerink Swann & Co analyst <span class="analyst">Howard Liang</span> said in a March 4 telephone interview.</span> <span class="company">Astellas</span> would need to offer $59 a share to match that premium, Liang said."If Tweet this