Two extracts from the 2012 GAIN legislation covering the FDA's new mandate -
[ ... the FDA should be encouraged to implement more broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases or conditions, including those for rare diseases or conditions, using a broad range of surrogate or clinical endpoints and modern scientific tools earlier in the drug development cycle when appropriate. ]
[ The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 505(c) or section 351(a) of the Public Health Service Act upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. ]
Arikayce is an example of the "innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases or conditions" the legislators were asking the FDA to fast-track.
The data from the studies in Pseudomonas infection and NTM infection are collectively "reasonably likely to predict ... clinical benefit" in any amikacin-susceptible pulmonary infection.
Why so little interest on the part of the FDA in a therapy "reasonably likely" to -
1. address an unmet medical need in NTM infection, for which there are currently no FDA-approved antibiotics
2. kill almost all of the pathogens specifically targeted by the GAIN legislation
3. reduce amikacin resistance
4. reduce clostridium difficile infection
5. reduce liver and kidney toxicity?
The BoD already recomended abbv sh's to vote against. As an 18 year shire owner I am fine because we will continue high growth for another ten years. This wouldn't have been possible as a combined company.
Besides, I won't have to write a big check to the IRS so our government can waste it!
1, if BOD will recommend stakeholders to disapprove the deal; OR
2, if BOD will make decision to recommend or not recommend stakeholders to disapprove.
I guess my question is at current stage, ABBV BOD decided or did not decide yet if they should continue the deal.
Always good to think positive, but will that result in Shire stock returning to 250?
They can't sue ABBV if no merger; they get about $1.6 Billion.
Looking back, Shire played hard to get, wanting ABBV to pay more for the marriage.
Combination market correction and potential tax law made this happen, unfortunately.
Waiting to see if Shire can make it back over 200.
Shire PLC (NASDAQ:SHPG) was upgraded by research analysts at Panmure Gordon from a “hold” rating to a “buy” rating in a report released on Thursday.
Several other analysts have also recently commented on the stock. Analysts at CRT Capital upgraded shares of Shire PLC from a “fair value” rating to a “buy” rating in a research note on Wednesday. They now have a $225.00 price target on the stock, down previously from $270.00. Separately, analysts at Zacks reiterated a “neutral” rating on shares of Shire PLC in a research note on Monday, September 15th. They now have a $271.00 price target on the stock. Finally, analysts at Leerink Swann upgraded shares of Shire PLC from a “market perform” rating to an “outperform” rating in a research note on Monday, July 21st. They now have a $269.00 price target on the stock. Eight equities research analysts have rated the stock with a hold rating, eleven have issued a buy rating and one has assigned a strong buy rating to the stock. Shire PLC has an average rating of “Buy” and an average target price of $221.55.
Shares of Shire PLC (NASDAQ:SHPG) opened at 170.49 on Thursday. Shire PLC has a one year low of $120.60 and a one year high of $264.98. The stock’s 50-day moving average is $251.4 and its 200-day moving average is $213.6. The company has a market cap of $33.325 billion and a P/E ratio of 30.34.
Shire PLC (NASDAQ:SHPG) last announced its earnings results on Friday, July 18th. The company reported $2.67 earnings per share for the quarter, beating the analysts’ consensus estimate of $2.45 by $0.22. The company had revenue of $1.50 billion for the quarter, compared to the consensus estimate of $1.45 billion. During the same quarter last year, the company posted $1.79 earnings per share. Shire PLC’s revenue was up 20.0% compared to the same quarter last year. Analysts expect that Shire PLC will post $10.03 EPS for the current fiscal year.
Sentiment: Strong Buy
I think it hits $192ish Should have a nice bounce back today. Everyone who sold - sold yesterday. Way over sold. I think people will be piling back in today and then of course, shorts will have to cover. They thought it would go down more, but the news was already out. We have a nice break up fee and off course this is a kick a__ company on it's own. Worth $230 a share without the buyout. So, win, win. Just wait - and be patient. Let the weak shake out this morning and it will surge up all day after that.
Sentiment: Strong Buy
BofA/Merrill Lynch analyst Graham Parry is telling clients to buy weakness in Shire (NASDAQ: SHPG) as AbbVie (NASDAQ: ABBV) turns away from the deal. The firm maintained a Buy rating and price target of $230.
While a simple 50% majority can push the deal through, the firm sees this as unlikely given an outright recommendation against the deal by AbbVie's board. That said the stock is fairly valued on a standalone basis, the analyst said.
"We would be buying the share weakness today, following our move to Buy yesterday, given an attractive entry price on fundamentals and a compelling standalone investment case," Parry said.
Sentiment: Strong Buy