Postet on Yahoo's TCLN board 06/05/99 by Lawsys_X

Since the accelerated approval process was initiated in 1992, the FDA has granted accelerated approval status to a total of 25 drugs. The average time required to grant an accelerated approval is 8.9 months. The last one granted was Dec 98 and the fastest time for any drug was 1.4 months. That was for Crixivan, a treatment for HIV. The longest time was 23.7 months for Actiq, a cancer pain management drug.

Of the 25 drugs granted accelerated approval most were HIV or AIDS related therapies. Four (4) were cancer related. These 4 were Actiq, Xeloda, Taxotere and Camptosar. Accelerated approval times were 23.7, 6.0, 21.6 and 5.6 months respectively.

Actiq is a very dangerous cancer pain management drug and this is why it probably took such a long time to approve.

Taxotere (Docetaxel), a breast cancer drug, took a very long time, 21.6 months, to get through the process as well. It was submitted in Jul 94 and approved in May 96. In Jun 98 it received final approval. Why this one took so long is not clear.

Camptosar, a drug used to in the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy, took 5.6 months to get approved. This accelerated approval was granted in Jun 96. Full approval took another 28 months.

Lastly, Xeloda which is also used to treat breast cancer went true the FDA accelerated approval review process very quickly, 6 months. Approval was based on results of a study involving 43 patients. The drug appeared to help shrink tumors in 25% of these patients. When this is compared to our plan to treat 40 patients in the Cotara Phase II trials or sample size seem inline with what's required for approval.

Based on the above it seems we might be able to expect a relatively short review and approval cycle if we have the data to support the approval process. Is the phase one data on 12 patients enough? No IMO I think not. Is the Phase II data from 40 patients enough? It sure should be especially if we get the expected tumor shrinkage. Now for the time lines.

In early DEC 98 the Company began begun treating the first patient in its Phase II Cotara trial. The Phase II trial as planned will enroll of 40 one-half of the study population will be from patients with newly diagnosed glioblastoma multiform (GBM) and the other half from patients with recurrent (GBM) or anaplastic astrocytoma (AA) in these Phase II trials. The protocol also allows patients to receive two doses administered eight weeks apart.

Given the proposition we are now almost seven months from the time the first patient was enrolled in Phase II there should be enough data to support the application. If not, there certainly will be within the next few months I would think. Therefore, base on the approval cycles of Xeloda and Camptosar. I expect accelerated approval by the end of the year or the end of the first quarter CY00 at the latest. Then again it could come in the next two or three months. If that happened though it would be a record for any cancer drug. So, on this one and like all the other events we anxiously await I suggest we all keep the old expectation bar low. Maybe then we'll get surprised.

Luck to all.