Replies to post #255906 on Avid Bioservices Inc (CDMO)

[GORMBUS]

GPUPPY:

Thanks a great perspective.

[jakedogman1]

thank you so much... my take is that both arms could be skewed given there could have been bavi patients that opted out as well....

imo getting human clinical data now is more important than continuing on a path that has no positive outcome....

[patientlywaiting]

Thank you for that intelligent post!

[hopefilled2014]

Sticky please. This post makes enormous sense of what happened and should be read by all posters. Too bad PPHM hasn't said the same in a PR.

[aikifredicist]

Thanks Gpuppy, that confirms my suspicion. The control arm was preferentially depleted of progressing patients.

[stoneroad]

Thank you. And thus why PPHM may have chosen to stop all chemo combo trials.

[volgoat]

That is called another mngnt bungle, Everyone in pharma knew from AACR and publications that I/o drugs were next and getting BTD and approvals. Even Pphm knew and jumped on the bandwagon changing Bavi to an I/o drug.


That is the reason a r&d biotech partners....even if mngnt was too ignorant or greedy to know the io landscape, bp would have.

[masshysteria]

thanks gpuppy and great to hear from someone on the ground working with patients and invested in Peregrine stock & science at the same time.

Very reasonable and balanced view of potential drivers of Sunrise outcomes and one based on realities of business, patient management and trial dynamics. Should give board members a comfort level regarding interpreting current state. Caution advised but most of the previous excitement driven by the potential of this platform is unabated.

Couple of thoughts regarding the Dr.'s scenario;

Geographic distribution of patient outcomes will be important in determining the pervasiveness of the drop out and follow up treatment scenario. Opdivo and Keytruda are available in the US for Lung (various sub indications) and therefore represent an absolute option for care givers and patients to consider. In Europe - only indications approved are for Melanoma and dosing for NSCLC will be very difficult to achieve though small numbers are possible based on special access. Also, joining Opdivo/Keytruda trials is possible for Doce arm patients but not to Bavi arm patients (usually exclude anyone with previous immuno-oncology exposure).

It's a different world out there and it changes weekly. It is great for patients and research, but very difficult to navigate and highly risky for Pharma/Biotech. That's why coupling with a leader who's helping shape the evolution is critical as the FOMO (Fear Of Missing Out) is a real and present danger here.

Best,

MH

[bfiest]

I have one question. Wouldn't the Bavi group have access to the same I/O therapy and wouldn't a doc do the same for a Bavi participant leveling the field? Or am I missing something?

[CuresForHumanity]

Thank you gpuppy- this is what I thought might have happened. This will have an effect on many current cancer trials across the board - won't it? BTW- My husband is an internist as well, but he has no interest in stock investments - well until this fiasco. Now he doesn't want me to look at a stock message board ever again and hand all money over to our investment advisor. Obviously I listen well - cause here I am reading/posting - :-)

What I'm unclear on is - where does this current predicament leave the company's short term financial situation? Can they recover from this situation without further shareholder destruction in the near term? This is why I'm 80% out on a huge loss. I believe in the science based on scientific publications and can see a demand in immunotherapy combo trials, but I'm unclear as to what this set-back will do to the company financially? Any thoughts? Wait a month, take the tax loss, let the dust settle?

[peregr]

Outstanding post. Validates what many of us were thinking regarding the trial outcome- and explains why the trial design was valid (for the time period). Just wish you had posted sooner so I could have saved 3 hours of reading.

[geocappy1]

Thank you for your perspective which some of us tried to say but w/o medical backgrounds. If the treatment arm had a better ORR and PFS then it would stand to reason that control arm patients would seek approved I/O options earlier as they failed to respond. This would lead to control patients getting additional drugs sooner. Heck, I bet if we let the control arm get treated with bavi after 1st getting the placebo for some time their survival numbers would also be similar to the treatment group. Dah.

Therein lies the argument for reviewing data, followup, etc and possibly construct g an argument to the FDA

[chevalblanc-47]

Thank you gpuppy.
If it's true that poorly doing patients were leaving for I/O, it's the perfect explanation.
But a trial like this is a total joke, you can't win. Will the FDA take this into consideration? Has anyone seen this situation in other trials?
But the positive is that this cannot happen in a Bavi/IO trial (if we ever do one)
Bought some more but just because it's trading at a big discount to NAV.
Kind regards
Danny

[Sparky80]

Mc
Cc

[hutschi]

So could that be the reason why they enthusiastically want to join the new IO study with durvalumab and bavituximab?
chemo alone wasn't good but with bavituximab there is a progress and with PD-L1 .....well maybe that could be the right combotherapy they want for their patients.

CP your thoughts?

[BCS Paladin]

Your post is most appreciated.

A real MD and a real contribution.
There seems to be a reality to a Phase III that I had no clue.

[JamesGMS]

gpuppy, thank you for your informative post which I have excerpted in relevant part below:

Given the stage and ECOG status in both the control and treatment arm were to be one and the same, I suspect these two patients were in the control arm. Any responsible oncologist is not going to allow his/her patient to die without a fight for the sake of a trial. Hence, they were terminated from the trial. If this decision was made for all patients who were doing poorly in the control arm, it is understandable to see why the control arm survival was much greater than historical data. Both the control and treatment arm survival is a bell shaped curve and if you remove the early deaths from the control arm, the curve shifts toward the treatment arm. Remember the treatment arm was performing as expected and hence the control arm was artificially skewed in that direction.

If practicing oncologist had no I/O options things would have looked very differently.

So once again I ask - and with the above analysis in mind - what does the FDA do if Garnick can show them that the Treatment arm was showing an MOS greater than 13 months ???

James