One day the stock goes up $5 then another $1 the day after only to give almost all of it back?! Just because of a biotech ETF SELLOFF?! EFFED up!😩
Because it's spring I guess. Seems the spring biotech meltdown is coming later this year. I thought we were safe getting through May be it seems not.
That's their self imposed "deadline" they don't have to make a decision by then. They were a day late with kalydeco s expansion label to r117. I expect if it isn't approved before July 3 it will be after the long holiday.
Most financial people I've talked to say they believe the decision will come by Friday July 03rd or possibly earlier. The 1 year anniversary of Kalydeco approval is June 24th. Doesn't mean the FDA is sentimental. Just putting it out there....
The FDA must make a decision by July 5th, but that is the Sunday of July 4th weekend. So what is the ruling or precedent for this? Does it effectively mean that they have to decide by Friday, July 3rd or are they allowed to push it off to Monday, July 6th. I'm trying to make some financial plans and it would be useful for me to know.
there to avoid high cost of drugs... why pay $300,000 when u can get copy in India for $1,300? See article on Express scrips trips to India
check out this video of a CF patient speaking about why she wants Orkambi approved. It will be kind of hard for the FDA to say no after listening to her! https://www.youtube.com/watch?v=3ARdU_FVAgA
Sentiment: Strong Buy
There is a critical point in Okrambi p3 combination, It showed that pulmonary exacerbations, or flare-ups, had been reduced 30 to 40 percent by Okrambi . This is extremely important parameter that FDA pay a lot of attention. FDA will approve okrambi combination just depends on this data.
Sentiment: Strong Buy
There is a critical point that write did not mention, p3 combination showed that pulmonary exacerbations, or flare-ups, had been reduced 30 to 40 percent by Okrambi . This is extremely important parameter that FDA pay a lot of attention.
Sentiment: Strong Buy
July 05 but that's a Sunday so has to be by July 03. June 24 is anniversary date of Kalydeco.
Not that the FDA is sentimental.
In addition to verity and Qdelfan input, let me throw in my 2 cents worth.
For the sake of argument, let's just say the FDA is not going to approve Orkambi. In that case they have to reiterate the flimsy reason they gave in their presentation to the ADCOM panel which was the improvements were due to Kalydeco and not due to Lumacaftor. Keep in mind it was the FDA that initially did not approve Kalydeco for the 8,500 additional patients who had 2 copies of F508del mutation genes.
So if they are saying Kalydeco is effective for this new group of patients as well, then logic dictates that they must approve kalydeco alone for these 8,500 additional patients which means VRTX would be able to collect an additional $300,000 for each one of these8,500 patients and does not even need to pay the cost of manufacturing Lumacaftor.
The voice of reason. Thank you for writing fact based truths rather than this Motley Fool writer's bunk. This writer tipped his negative bias when he wrote the line that "the FDA would laugh in the faces of Vertex owners" in reference to a particular trial aspect. He was about as unprofessional as you can get. Thank you for calming me down.
If you want risk free investing why are you investing in any stock, and biotech stocks in particular?. Sell VRTX now and reinvest your shares in a CD or T bill. They're insured by the US government. (If you consider that risk free) The yield will disappoint but you will not lose any sleep over a negative piece posted on the internet by an author who works for the Motley Fool whose expertise in VRTX you have no idea about, and whose motivations and biases may be based on supporting short side investors who would benefit by 'spreading fear' that you allude to. Of course their is a risk of a negative vote or a delay every time the FDA has to approve a drug. But you are aware that the FDA ADCOM committee voted overwhelmingly for the FDA to approve Orkami and the FDA generally follows the ADCOM's recs, and the ADCOM committee scolded the FDA presentation for making an issue of a statistical analysis comparing across separate PHASE2 and Phase 3 results when that raised the question as to whether the Ivacaftor component of Orkambi was responsible for the safe and undisputed demonstrated clinical benefit seen in the 508dd CF population in Phase 3 trials, the first trials that ever gave evidence of slowing the underlying cause of CF in the majority of CF patients, thereby giving a reasonable chance of prolonging the lives of these patients as well as improving the quality of their lives. The FDA approved the trials without a monotherapy arm and have not required VRTX to include a monotherapy arm in the ongoing VX 661/770 Phase 3 trials in the same CF population currently underway. Verity is right that it makes no sense that the FDA would reverse itself and require monotherapy arm trials before approval and deny these patients the safe and demonstrated benefit when there is no other treatment option comparable currently available to slow the progression of their otherwise fatal disease. The motley fool author is truly a 'foolish' advisor in this case.
Verityvoila-so what do you say to the author after reading this article? He says Vertex has a mountain of risk. And do do shareholders. Is the writer misinformed? Or doing what Wall Street does so well: spread fear??? How can you say there is no risk owning Vertex Pharma stock sfter what this story says? ??!!