Replies to post #189050 on Biotech Values

[honestabe13]

it has been stated repeatedly on this board that as long as Phase IIs are shown to be safe, companies can move to Phase III trials.

Not true.

FDA requires that Phase IIs show evidence of effectiveness.

If PPHM's reconstituted data from the messed up P2 was good enough for the FDA, why isn't it good enough for anybody here?

[vinmantoo]

{{I guess the FDA approves all
Quote:
corrupted phase II trial
results and awards fast track status with 2 interim lookins?

WHY DIDN'T the FDA force a redo? Did they see something or are they into risking patients lives

I don't know...do you?}}

Why do PPHM longs always repeat the nonsensical "Why did the FDA give approval for Bavi for phase III". I will give you credit for the "why didn't they make them redo a phase II trial to because their NSCLC trial was corrupted" nonsense as it is original.

How dense are you PPHM longs? The FDA doesn't care if any company wants to waste their money by pushing forward into a phase III trial before solid data from a strong phase II trials shows good efficacy. The Bavi NSCLC till was a combination of Docetaxel + Bavi vs Docetaxel alone, the standard of care. There was no obvious heath issues with the combination. The FDA would not block PPHM from going into a phase III trial of docetaxel + glucose vs docetaxel alone.


{{PPHM reconstituted data...60% increase in MOS and STAT SIG...What do you suppose would have happened without the dose switch(pronounced sabotage)?

NY Academy Science presentation reiterated >110% increas in MOS? Is that what the FDA sees??}}

What PPHM presents is irrelevant. Hard data is what counts. The number of patients in the Bavi 3mg/Kg arm was very small so is subject to large changes in MOS with just a change in a very few number of patients. What if two patients died sooner, or three in the 3mg/Kg arm? That small population makes is extremely important for patients to be properly staged before entry into the trial, and how much pretreatment they had. Data from very small trials that aren't corrupted should be taken with a grain of salt. Data from very small trials that are corrupted should be taken with a shaker of salt. Provide new data or shut up.

[biopharm]

Wook...many months have passed now and it looks like the FDA may have seen the 100%+ MOS improvement on the phase III Sunrise. ESMO has the first crack possibly....at releasing the Embargoed biomarker data on Oct 10

One week away....NO reverse split and an easy climb back to $5+ coming....just as was seen back in Sept 2012

Unbelievable that many did not realize it was sabotage all along