Replies to post #8715 on Avid Bioservices Inc (CDMO)

[mskatiescarletohara]

Actually, I think SK and Thorpe are more involved here than we think. I know for a fact Thorpe was frustrated with the FDA process just in getting Phase I approved.

Given the company's current clinical status i.e. cancer Phase I, and HCV repeat dose, they had to make a decision to move forward. India provides that outlet, my only concern about India is I worry this crowd will partner with some unknown, wannabee a CRO too in the very rapidly growing CRO/pharma market there. That's all. Who's going to fly to India and make sure the protocol is being audited? Is PPHM going to hire an outsider in India to check on the CRO and make sure proper consent is given, doses etc. Is the facility FDA inspected, if it works is this a company they can continue to do business with, have they had success with the EMEA...

I hope Bavi works, the pre-clinical data is compelling, although will the similar safety profile remain the same as achieved in Phase Ia....we don't know. The safe harbor statements have changed, now that the combo study is advancing. Will increasing chemo uptake increase side effects, can it be dosed without any SAEs? We shall see.

katie....

[mskatiescarletohara]

Lamma lamma lamma ding dong...maybe it's Lambda...

DCGI approves Lambda, a CRO, to conduct Phase 1 trials first time in India-(Yahoo News-10/05/2004)

The Drug Control General of India (DCGI) and the Indian Centre for Molecular Research (ICMR) has cleared the first Phase 1 trial project to be conducted by an Indian Contract Research Organisation (CRO), the Ahmedabad-based Lambda Therapeutic Research. Currently the biggest contract research organization (CRO) in India, Lambda has recently been contracted by an Indian pharma major to conduct Phase 1 trial of a new molecule in the country. According to Ashish Kumar Dasgupta of Lambda, there will be two trials of oral and intravenous dosage forms and are scheduled to commence around the third week of May.

It is the first time an Indian CRO is engaged in conducting Phase I studies. The protocol has been approved by the DCGI and ICMR last week, he said. He informed Pharmabiz that there are few more Phase I studies under various stages of discussions for the CRO. It may be recalled that Lambda was also the first Indian CRO, which has two clinical research facilities in India. It has 100 beds facilities at Mumbai and Ahmedabad for the conduct of Bioequivalence studies. Lambda is conducting almost six to eight pivotal studies a month for submission in Europe and US. The CRO now awaits USFDA inspection, which is expected to begin soon. Lambda is equipped with 12 HPLCS and 4 LC/MS/MS. Very soon few more LC/MS/MS will be added to enhance the bioanalytical capability. Lambda has also forged into phase II-III trials in various therapeutic segments like Anti-cancer, gastro-intestinal, autoimmune disorders, respiratory diseases etc.

[Big On Tarvy]

Xzone, You hit the nail on the head:

“I think they are going to india to prove....Yes prove, that Bavi is Kick ass in combo therapy.....

Cutting thru all the red tape, FDA bullshit, and proving to the world and big pharma, that you had better pay attention now....”


This is also how I understand the Company’s strategy. Go hard and fast on Bavi AC combo studies. According to SK in the CC, 12 patient combo trial will complete “approximately around year end or early in the new year.”

The company knows the pps will rock when the combo data comes in because of results already seen at M.D. Anderson in mono therapy trial. Official India combo results may not be announced until spring, but the pps will start moving through the BP and doctor grapevines when the eight week study finishes “around year end or early in the new year.”

By Feb or March, it will be clear that the HCV, HIV, CMV and influenza programs are "just the gravy," as Xzone put it. The smell of the sizzling AC steak will be all through the house.
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The only new thought I would add is to watch Glaxo. They are a big player in India now. Consider the possibility that the reason PPHM was able to pull off this BP-style play in India is because Glaxo walked them through the doors in exchange for the right to be the first to know the Bavi results. What a headstart that would give Glaxo in the BP courtship game for the next mega blockbuster.