NI,
Thanks very much for yours views on Cerestat.
Although, I have several points for disagreements regards the Cerestat, most at all I have, as layman, serious problems swallowing recommended companies list for mid. 97. Actually, CEPH, IPIC, NXCO are also recommended last year and under-performed market heavily.
From short press release(didn't read letter) to me looks like all recommendation are based on near-term events (assuming positive) and not on company fundamentals and long prosperity. Several good Neuro bt with solid fundamental, like NRGN, SNAP, SIBI, NBIX,...) are for some reason excluded.
CEPH recommendation based on speculative (political/public pressure) FDA Myothropin approval, even if FDA give green light for non-effective drug how will Congress and public force Dr's. and Health Ins. to prescribe drug? Maybe by massive lay-off threat or de-licensing of the doctors practice!!, is out of the any logic and professional ethic. For the future of the US Health System and FDA rule hope they will be able to defend their position and reject Myothropin.
NXCO antihypertensive drug Corlopam has limited market and drug itself has disadvantage over current marketed drugs. It means that potential revenue are very limited and can't significantly contribute to price valuation. Second, SNX-111 definitely will not be black-busters drug for severe pain and TBI. WL and Medtronic clearly indicate this. Company itself is moving to other field, cardiovascular, by Corlopam pro-drug development. This is actually positive news, but NXCO luck experienced stuff for this field. Why is than company recommended as buy?
IPIC Redux is *cosmetic* drug with very short period of the therapeutic effects and significant side effects. Drug had only by AHP strong marketing campaign some sales, but this will decline further as new drugs, better and safes, reach the market. What are basic reason for believe that Citicoline will have positive PIII data? This molecule/parts contribute in *neuro-comunication*, not neuroprotection or neuroregeneration. It was surprise that in first trials show some positive results. Anyway, Citicoline will be *cosmetic* drug for stroke and TBI (will love to see EU sales numbers!). Limited potentials. The only near term light is Bucindol, but it is own by Intercardia drug, not IPIC. Target price, 35, is way off.
Regards the CNSI and Cerestat, I do not have problem with HOLD recomendation. From day one I stated that it is high risk company and Cerestat may have big problem with toxicity profile as many up to date potent NMDA antagonist. Preventing the excitotoxic cells death in stroke is prime objective. NMDA and AMPA receptors has to be blocked.
Because CNSI didn't release which type of the side effects caused trials halt, it is to speculate that lower dose may have acceptable safety profile (tents of the TBI dose) but therapeutic benefits are under question. I do not know why projected time for TBI and Stroke interim data are moved for one month. It is in CNSI best interest for as soon as possible to unveil this data. If only one dose have promise for trials continuation than this trials for stroke can be valid for FDA. Depend on the results the new trials may be necessity. Completely dosing change normally discharge current trials.
For TBI Cerestat may have positive clinical data. Why will CNSI hold info from interim data whatever they are? Regardless they are or not in correlation with other drug/trials, SEC and SH will demand data which are normally available from interim. Nothing more, nothing less. CNSI is public company and it has to play by SEC rule. Also, this data may have no correlation with Stroke trials regards the safety. This is two different disease, not young or old patients. Stroke do not come suddenly for no reason as TBI develop. Stroke patients already have some health problems and Cerestat may have much stronger side effects in this population. TBI victims are normal healthy individuals. By this, I agree with you that TBI trials have good chance to be positive. CNSI and BI are aware of this, and IMO if there are indication for believe that TBI trials data are sufficient positive, the company will disclose them.
Hope at Aug. end we will have good news. My problem is not Cerestat! What is in research and development, business plan, product pipeline is what worry me. One drug company is for none investment.
For instance, will CNSI have presentation at "Excitatory Amino Acid Symposium 1997" on July 17-19 at Waterville Calley?
CNSI is not first or last bt company which may have PIII failure. This is not the end when company prepared itself for such events like REGN did. There are difference in management and how development company mature from *amateur* to professional player. Hope CNSI management has grow-up! For their and ours good.
mz |
