..."It's unclear what the next step for Bristol-Myers will be. A spokeswoman would say only, "We are actively evaluating our options in view of yesterday's meeting with the FDA."
The drug is delay minimum one year.
Out of 25 "responders" 15 did not met inclusion/exclusion criteria.
That leave 10 "responders" and of those many of the x-rays and Ct scan were/are "missing".
Quality of the "solo" trial is must probably about the same, Why should it be precise and careful? NO, it is coming from same Imcl that refused to work diligently in the "combo" trial.
The Merck KGaA trials is not looking at survival as endpoint it is looking at "tumor shrinking", fine, but it is not a clearcut proof of increase survival or quality of life, and the results are not warranted to be better than current trial (apparently Mercky trial execution quality is the only warranted here, do not confuse that with certainty of good results, good as meaning an effective drug).
The most probable results from a large, well designed, well executed trial is TRUTH and confirmation of effects. With current poor combo trial data the most consistent effects are lack of effectiveness, not otherwise.
A maybe does not justify a $1B market value
Imcl market value should be the cash, and the expectation of drug approval and development stage. The cash is fine, the expectation is mediocre at best, only important part of development stage is that the drug is in clinical trials (pII and pIIIs) and Bmy (sour)sponsorship.
Market value should be $0.5 billion ($7 to $10 per share), anything more is way too much for the risks.
Risks are higher cause of the well known trial results, not lower. |
