Magnitude is sufficient that at least one educated person with access to the data was sufficiently concerned to pull the trigger on an early review. My interpretation of that is that the problem is out of the ordinary in terms of significance.
Discontinue the drug on reaction! Of course, how easy! Problem is that the patient is hypotensive, requiring pressor support or tachycardic requiring cardioversion (these are not hypothetical situations, they happened in the phase 2 trial). I'm an interventionalist in the middle of a case, the last thing I need is a nurse on speakerphone telling me that my other patient is crashing. The devil is in the details and this is exactly the kind of detail that cannot be blown off.
If I understand you correctly, and I think that I do, in 2 weeks time the share price is going to be higher or lower. Thank you for this! I think I will buy (or sell).
Agreed. Somehow, the regulatory agencies have to figure into the discussion on how to move forward. This implies weeks to months before we know anything (not days as some on this board are speculating).
The notion that we will hit 10, or even 8, prior to clarification on the above is a dream in my opinion.
As always, would love to be wrong on this...
Does anyone know if there is a mechanism for vintafolide to be referred back to the CHMP? At this point it seems obvious that they would adopt a negative opinion. However, ECYT and MRK cannot spend more on vintafolide for PROC without some discussion with the regulatory agencies as to what would constitute a successful application. Would data extracted from the current study suffice? (probably not) Would a new Ph3 trial be necessary? How would the trial be designed to avoid whatever problem there was with the PROCEED trial.
All of this, I think, will take months to work out. It has only been one week since the DSMB decision. There is still a long way to go. It would be nice to have an update from the company before the next conference call (say, in 6 weeks or so). Probably, very little chance of that... Would be interesting to see if they pop up on the CHMP agenda over the next few months.
Even if a Ph3 lung CA trial started today, you're looking at 18-24 mos before you see any data.
There is no way the EC can grant marketing authorization now. Even if they did, what doctor in their right mind would prescribe the drug. What payer would pay for it?
The folate tubulysin drug is just starting Ph1. So, a 3-4 year wait on that one.
This company went from commercial stage to early development stage overnight. In the process, they burned their bridges on Wall Street (remember that $21 secondary offering?) and raised serious doubt as to whether they are capable of running a proper Ph3 trial.
It takes a major suspension of disbelief to buy this stock at anything more than 6-7 until there is more clarity. Maybe Merck will pull a rabbit out of the hat, but not counting on it.
BTW, PCYC got their drug across the goal line. ECYT was running for a TD, tripped, and fumbled the ball...
OK, sorry, rant is over now. I feel much better.
A few additional thoughts on Merck:
1. MRK stock has been on a tear for 6 months, so they have some additional currency there beside the $15B.
2. In my opinion, their earnings report was a disappointment. Revenue was down. EPS up due to cost-cutting. That's not sustainable. They need growth. I think they need ECYT more than ECYT needs them at this point. That's a great position for ECYT to be in.
A couple clarifications:
In the second paragraph "#$%$" should read "5." Median calendar days to approval should read "59."
Also, I believe that 52 days is an idealized best case scenario. In real life, no drug made it through in 52 days.
I have been spending some quality time with the EMA website. This is what I have learned:
The process that takes us from positive CHMP opinion to final approval occurs in 3 steps taking 15, 22 and 15 days (total 52 calendar days). There is some provision to expedite the 22 day step to as little #$%$ days in extraordinary circumstances.
So, I reviewed every initial marketing authorization application in 2013 to find out what has happened historically. I ignored negative opinions, extensions of indications, generics, reexaminations, etc.
59 drugs received positive CHMP opinions on initial marketing authorization in 2013
58 were granted marketing authorization by the EC
1 is still waiting on an EC decision (pos CHMP opinion in 11/13)
The EC never went against the CHMP opinion in this group in 2013, not even once.
Of the 58 that were approved by the EC in 2013:
Avg calendar days from CHMP positive opinion to approval was 70, StdDev 37, range 54 - 315
Median calendar days to approval w#$%$9
For reference, positive CHMP opinion on the 3 Endocyte compounds came on 3/21/14.
Since I am getting out of the forecasting business, I will let you come to your own conclusions.
All i am saying is that the management of the company has a choice. They negotiated a bad deal for us (the shareholders) and they need to own that. Apologies if i offended you. that was not my intent and i appreciate the insights that you have shared on this board.
I don't disagree, but "the bankers made me do it" is a cop out. It's the kind of excuse i get from my 6 year old...
The management of this company (the people in the know) went on record with their belief that this stock is only worth $21.
There is no further news on vintafolide development until June (PROCEED decision) and folate-tubulysin until much later in the year. Until then, we drift.
The CHMP decision was great, but without information on rollout schedule and pricing/reimbursement in Europe it is anyone's guess as to how much actual revenue the company will see and when that revenue is expected to come in. I hope we get this info on the next call. One might speculate that the larger than expected secondary offering may have been a signal that the revenue potential of vintafolide in Europe may be lower and later than what they previously believed.
Like others on this board, I am a huge fan of the science here and I believe that it is only going to get better with the tubulysin agent and platform development in general. That's the reason to own this stock (well, that's my reason anyway). However, the overhanging questions are going to weigh for some time.
This is an important point. The same one I was making back in Nov/Dec when we were stuck in the $8-$12 range.
Take a look at the one month On Balance Volume chart. It shows a nice graphical representation of what you are saying, no math required.
(Before any technical traders get all in a twist, I realize that this is not how you guys use the OBV, but it is relevant to the point being made above)
There's an old Dylan song called "You ain't going nowhere" . It's a great song, worth a listen if you haven't heard it. The lyric relevant to your question is:
Strap yourself to a tree with roots
You ain't goin nowhere
Any thoughts on that Harb ELCC poster (on the Endocyte website)?
To my eyes, this early data on vintafolide for pre-treated adenoCA in the lung looks promising in the FR100% group.
They broke this stock. I think that we will be stuck in the low 20s for the next few months, praying that we don't see the teens. There are some things to look forward to, but all are months away:
PROCEED expansion decision
More TARGET trial data, esp wrt adenoCA
More data on the folate-tubulysin drug
Buyout? Nobody will know anything and then suddenly it will happen, or it won't. I'm not counting on it, but would love to be wrong.
In the meantime, your advice is right on. My cost basis is in the 13s and I've got nothing but time.
Though levels of ³H-vintafolide uptake by the RFC-expressing PC43 cells were similar to that of ³H-MTX, no inhibition of ³H-vintafolide uptake was seen with PT523 suggesting that this uptake is not mediated by the RFC. As expected, very high ³H-vintafolide and ³H-etarfolatide:Re binding and uptake was seen in the FRα-expressing RT-16 cells, and this uptake was competable with excess FA indicating that the interaction was specific to the FR. Collectively, these results show that vintafolide and etarfolatide are specifically transported via the FR and are not substrates for the RFC or PCFT.