Replies to post #311111 on Avid Bioservices Inc (CDMO)

[BioBS2012]

North40000, Yes I read that article. IMO just because it is run through NCCN doesn't make recruiting any easier. Most of these institutions run several studies at the same time for the same indication, so there is internal competition too.

In the case of Glioblastoma, I did a screen on the following key words:

Radition + Temozolomide in Glioblastoma. Further narrowed the search to studies that are active but not yet recruiting, recruiting, and recruiting by invitation. I came up with a list of 82 studies !!!

https://clinicaltrials.gov/ct2/results?term=%22Radiation%22+and+%22Temozolomide%22&cond=Glioblastoma&Search=Apply&recrs=b&recrs=a&recrs=f&age_v=&gndr=&type=&rslt=

Even when narrowing it down to Massachusetts General Hospital, there is another study being run there with Avastin in combination with other drugs started a year earlier - 85 patients. SO there is competition within the same institution also for patients. Doesn't give a warm and fuzzy for the PPHM study finishing in any meaningful timeframe.

https://clinicaltrials.gov/ct2/show/NCT02843230?term=%22Radiation%22+and+%22Temozolomide%22&recrs=abf&cond=Glioblastoma&spons=Massachusetts+General+Hospital&rank=2

Yes, there is some truth to the "slow and steady wins the race". However, this is already the mountain stage of the Tour De France and if you are happy hanging behind saying we will catch up when the going is downhill, well you literally will be going downhill.

JMO.

[bfiest]

It would seem that Ronin does have the correct approach from a business standpoint in light of the issues highlighted in this article. It's a perilous process out there to get a drug approved for limited numbers of patients that meet much more defined criteria. I mean how do you navigate the complexities of competing against literally thousands of other trials with limited patient availability. Yes the trials can be approved with smaller patient populations but is it prudent to believe that our current group of leaders could successfully find their way through such a complex maze? In my opinion absolutely not. Business sense indicates the only logical approach is to deal the science in such a competitive perilous market. It would seem that one would have to make very calculated, concise and correct moves in a field of unknowns to develop a winner in such an environment. It is not prudent from a business standpoint to continue down the current path especially knowing the type of deal that the current BOD would demand before they would ever give up their current control. They have it too good at our expense and there is no conscience behind their greed. It's the ultimate catch 22 in my opinion. It's time to give up the pipe dreams of a few and get practical. Dealing the science only makes sense in such an environment. And the current group will not make the kind of deal necessary to move the science forward. The environment does not support such a deal. That is so obvious now in my opinion. Bring on any practical alternative. ANY! These guys MUST go. I am sure we will now hear how the only practical solution is to continue down the current path because approval can happen with limited numbers of patients even though the competitive and complex scientific landscape screams otherwise. We need to get real.

[sunstar]

“...there also were drugs approved without control groups...”

“...the F.D.A. has not insisted on large trials with control groups...”

Peregrine has suffered through large ‘over achieving control arm anomalies’ in a number of its cancer trials, where the Bavituximab treatment arm performed strongly, as per design.

Starting with the 2012 phase ll NSCLC trial, where the control arm was sabotaged by a person at the contracted CMO. The 3mg/kg Bavi arm was not interfered with, and performed strongly, doubling standard survival.

These over achieving control arms made it impossible for the FDA to accept any of these Bavituximab trials.

This happened way too often to have been by chance.

Only the control arms were irregular, the active Bavituximab arms performed per design, and as expected by Peregrine.

What seems obvious is that whoever may have engineered these over achieving control arms did not want to damage the active Bavituximab arms. The ultimate perpetrator had an extreme interest in Bavituximab, anti-PS technology.

So much so, that the interfering party was willing to act illegally on multiple occasions. That amounts to an astronomical risk.

Recently, a hedge fund has taken a run at PPHM for control of the company.

What’s in the works for anti-PS technology??

The pressure on shareholders has been immense.

IMO

sunstar